Can you tell me what is Clinical Data Management Quality Assurance I want know what it actually is ? Quality Assurance in Clinical Data Management is a paper represented for discusses the organization, procedures, and technical methods used by Quality Assurance unit to certify data processing quality and data integrity .
I want to get details of Clinical Data Management Quality Assurance of Massachusetts Biotechnology Council so will you please provide me that ? The following errors occurred with your submission Okay Your Username: Click here to log in Message: Options Quote message in reply? Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising.
LOGYCLI  is a leading biopharmaceutical company creating better products utilizing innovative drug delivery technology.
With guidance from the Chief Medical Officer, the Associate Director,Our  Clinical Operations team will manage all aspects of clinical operations for assigned clinical trials to assure the highest standards of clinical trial execution and GCP.
LOGYCLI  Clinical Research professionals apply their therapeutic, regulatory, and operational expertise to consistently solve the challenges that arise during all clinical projects.
Our core competency is project management, underpinned by comprehensive and consistent processes, which conform to global regulatory requirements and ISO9001:2000, and a culture that is focused on delivering quality information to clients. LOGYCLI  for clinical operations also drive industry compliant reimbursement management strategies, implementation of proven practices and effective workflow processes for enhanced efficiencies and sustainable financial performance. LOGYCLI clinical and administrative operations specialists provide a comprehensive assessment of all components of your agency operation. With over 25 years of experience designing and implementing effective staffing models, Transpirus can help you identify appropriate staffing ratios, opportunities for improved workflow processes, and assignment of role accountability to drive cost effective care delivery models that generate positive patient outcomes and improved compliance oversight. Compliance and Regulatory: LOGYCLI provides compliance solutions to help minimize risk and preserve your organization’s valuable assets.
LOGYCLI for Coding help you preserve revenue, minimize risk and identify staff education opportunities.
With a skilled team of tenured home health and hospice RNs, many of whom hold HCS-D and COS designations, LOGYCLI can provide periodic chart audits to evaluate compliance with Medicare Conditions of Participation, quality of clinical documentation in support of billing submitted to Medicare and coding accuracy. Buyers engage LOGYCLI to evaluate acquisition opportunities, provide comprehensive clinical due diligence services, advise them in a transaction and support integration planning. Appropriate reimbursement and quality patient outcomes begin with your front-line clinicians.
Clinical data management encompasses the entry, verification, validation and quality control of data gathered during the conduct of a clinical trial. LOGYCLI delivers high-quality, cost-effective solutions to ensure the successful management and delivery of clinical trial data. We lead the way in the use of the technologies and standards and our Data Managers are proficient in the use of a wide range of technologies including Electronic Data Capture (EDC), Oracle Clinical®, Clintrial™, Frame Maker™, E-diaries, Optical Scanning and workflow systems.
Our experience and understanding of Electronic Data Capture (EDC) processes and systems enables us to provide the optimum solution for each project.
CDM services are available as part of our integrated service offering or under a complete or partial Functional Service Provider (FSP) relationship. Our Team has many years of Industry experience working with two fully validated clinical data management systems – Phase Forward’s Inform Architect and Oracle Clinical & RDC – as well as working on our customers’ systems provided by other vendors. Consistent data quality is our top priority for clinical trial data management – LOGYCLI is committed to customizing data management solutions that emphasize transparency, integrity and accountability as much as speed and accuracy. LOGYCLI’s Checkpoint Data Validation Services facilitate the early detection of potential data conversion and compliance issues. Our three-tiered approach offers flexibility and provides an opportunity for clients to leverage our expertise to improve data integrity. Basic Validation: LOGYCLI conducts basic validation of datasets (105 FDA checks, plus 4 JANUS checks). Enhanced Validation: LOGYCLI conducts enhanced validation, which goes above and beyond the basic validation and includes an additional 200 checks that verify SDTM compliance.
LOGYCLI’s enhanced validation offers extended value by raising the bar on compliance checks.
We can convert and validate your critical data or validate data that was previously converted prior to submitting to the regulatory agency.
Pharmacovigilance  also known as Drug Safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
LOGYCLI offers complete Pharmacovigilance services, which include data collection, processing, medical review, safety writing, report writing, reporting, signal detection and analysis. Following the recent withdrawals of many blockbuster drugs, Pharmacovigilance has become a critical phase in the Clinical Development Programs of pharmaceutical companies.
LOGYCLI Pharmacovigilance is uniquely focused on providing comprehensive and customized Pharmacovigilance (PV) services and offering specialized services to augment or support any drug safety department, tailored to fit your needs. Experienced and qualified project managers are your primary contact point; they are responsible for project initiation, continued management of your PV needs and will anticipate potential future needs. The monitoring of clinical trial safety and the continuing post marketing safety are vital responsibilities for pharmaceutical companies. Processing and reporting of adverse drug reactions (ADRs) from the post marketing area In LOGYCLI safety database.
Preparation and Update of risk management plans (EU-RMP)IT INFRASTRUCTURE AND SAFETY DATABASE:Do you need comprehensive end-to-end Pharmacovigilance services to meet the demands of the worldwide regulatory authorities? Medical imaging is the technique and process used to create images of the human body (or parts and function thereof) for clinical purposes (medical procedures seeking to reveal, diagnose, or examine disease) or medical science (including the study of normal anatomy and physiology). LOGYCLI offers an impressive, sustainable track record of successfully applying and managing medical imaging in clinical trials. Clinical study sponsors increasingly rely on imaging as a surrogate endpoint in support of efficacy and safety.
LOGYCLI  offers the necessary operational and technological infrastructure required to conduct an independent review. The imaging solutions from LOGYCLI  are powered by an integrated suite of proprietary technology tools.
Tracking: Workflow managementapplication, enabling completeand proactive management of the entire image lifecycle throughreceipt, quality control, evaluationand final results, all backed byaudit trails of image manipulations. Reporting: Cutting-edge reportingsolution with highly interactive features where users can drill into and interrogate data as wellas access ready-made MCC(Metrics Champion Consortium)reports for industry-standardperformance metrics. Export :Delivery of validated,clean and accurate data utilizingan integrated, multi-step approach that ensures total quality controlacross the entire workflow.
These imaging technologies are partof the integrated eClinical platformfrom Perceptive which workstogether to accelerate businessprocesses by optimizing interoperabilityacross our products aswellas with third-party and customerproprietary systems. Our compliant image processing and analyses with blinded independent reviewers provide standardized data with reduced variability. LOGYCLI provides transparency to the current status of each image in the image lifecycle process. We have capabilities spanning the application of novel imaging techniques in early development to widely validated methods for registration trials. Logycli’s Self-service Portal enables you to fully create, deploy and manage your studies on your own, from one central location. Clinovo’s CRFs Builder ‘Forms Studio’ allows you to create and manage your CRFs without programming knowledge. Logyclin Capture’s Edit Check Builder is your drag-and-drop graphical interface to build rules within Logyclin Capture without any programming experience nor IT expertise. A Clinical Trial Management System (CTMS) is a customizable software system used by the biotechnology and pharmaceutical industries and clinical research institutions to manage the large amounts of data involved with the operation of a clinical trial. LOGYCLI understands the importance of selecting a successful Clinical Trial Management Team, which includes, accounting for the complexity of a project, using effective management, and identifying the demands related to the execution of a project.
Clinical trials constitute the single most expensive component of the entire drug development process. A CTMS (Clinical Trials Management System) yields immediate efficiencies and cost savings for clinical operations.
LOGYCLI CTMS is a leading solution for pharmaceutical and biotechnology companies of all sizes.
Our Professional Services team is committed to helping clients accomplish a successful implementation of LOGYCLI CTMS and to benefit from the true power of CTMS.Whether implementing LOGYCLI CTMS as an on-premise solution or as an on-demand, software-as-a-service (SaaS) application, our Professional Services team will provide a flexible combination of consulting, professional services, validation services and training to support the full range of customer requirements.
The LOGYCLI CTMS Professional Services team consists of experienced product and technical consultants with a deep understanding of the system and extensive medical and clinical expertise.
Technical workshops hosted by our consultants on a variety of topics will train and prepare users for installations, up grades and ongoing operations.These workshops can be performed remotely or in-person. CDISC is the most significant development for convenience in data exchange without confusion within the pharmaceutical industry and between the industry and regulatory authorities.
LOGYCLI has blended deep standards experience and well-tested data conversion processes with our global R&D footprint, operational excellence and leading-edge tools and technology (see Figure 1). We understand the intricacies of converting raw data into the SDTM format and have the knowledge to anticipate cause-and-effect relationships, exceptions and nuances that are unique to your environment. On July 21, 2004, SDTM was selected as the standard specification for submitting tabulation data to the FDA for clinical trials and on July 5, 2011 for nonclinical studies. SDTM is built around the concept of observations collected about subjects who participated in a clinical study.
Qualifier variables, which include additional illustrative text, or numeric values that describe the results or additional traits of the observation (such as units or descriptive adjectives).A fifth type of variable role, Rule, can express an algorithm or executable method to define start, end, or looping conditions in the Trial Design model. The set of Qualifier variables can be further categorized into five sub-classes.Grouping Qualifiers are used to group together a collection of observations within the same domain. Result Qualifiers describe the specific results associated with the topic variable for a finding. Synonym Qualifiers specify an alternative name for a particular variable in an observation.
Record Qualifiers define additional attributes of the observation record as a whole (rather than describing a particular variable within a record). Allows companies to add additional domains and variables outside of the CDISC controlled domains and variables. Simplifies cross study analysisWhile SDTM provides a standard and ample flexibility, it can also become tedious and lengthy. The SDTM standard has been endorsed by the FDA and embraced by the pharmaceutical industry. The use of metadata within clinical processes has been steadily growing across the industry as sponsors try to become more efficient and consistent in executing clinical trial data flow. Across the industry there exists a broad range of practices on how sponsor organizations are managing their metadata. Lack of standardization in clinical trial data has the potential to impede the review and approval process for new pharmaceutical products.
As experts in the mapping of clinical and research data, LOGYCLI can ensure a successful mapping strategy is put into place and then delivered. LOGYCLI have been involved in a number of successful mapping projects for submission, reports or publication purposes. In the past each sponsor built integrated databases for submissions based on his own standards. The LOGYCLI Biostatistics department has in-depth experience in the development of compound specific ADaM data.
For clients with limited experience in CDISC or ADaM LOGYCLI provides guidance in the development of CDISC products. The documentation which accompanies the derived data is only produced after successful validation of the data towards the defined ADaM model. Respecting the principle of limited procedures between ADaM data and the final results, LOGYCLI is able to create statistical results in an efficient way. The Operational Data Model (ODM) is designed to facilitate the archive and interchange of the metadata and data for clinical research,its power being fully unleashed when data are collected from multiple sources. The use of open standards can considerably reduce the coasts of electronic data capture (EDC) in clinical research.
With classic EDC systems, the system has to be set up “by hand” for each new study that is started, and the eCRFs need to be designed and created using information from the sponsor which is, at best, delivered in the form of Word or PDF documents. Conditions and conditional processing: the design can state the conditions under which a visit must not be performed, a form must not be used, a question must not be asked, and all this as well in machine-readable language (most useful in eCRFs) as in human-readable language (most useful in paper forms).
For an EDC vendor, software was developed to export the study setup in ODM format, and to import clinical data in ODM format into their Oracle-based system.
The results have been presented at the European CDISC Interchange 2006 in Berlin. A copy of the slides can be found here. For a young, rapidly expanding EDC vendor in North America, software was developed to automatically set up the clinical database and EDC system automatically from CDISC ODM files with metadata (including AdminData), and to import clinical data in ODM format into the existing EDC database.

With these new capabilities of their EDC system, they can also attract new customers that want to start using EDC, even in the mid of a running study. Special features of EDC that are not covered by the core ODM, can easily be incorporated in the ODM XML-schema by using a “Vendor Extension” XML-Schema. Another advantage is that with such a vendor extension XML-Schema, data can be send to the regulatory authorities in ODM format although they contain data for the extra features: the ODM Extension XML-Schema is just send together with the ODM files to the authorities.
Remark that regulatory authorities more and more ask for additional data for individual subjects, which they prefer to come in CDISC ODM format. Consultancy for and software development for automated transformation of ODM study setups into eCRFs.
Additionally,Medidata Designer,and innovative,eClinical Design solution designed to allow sponcers focus resources on the science of study design,is the only ODM-certified application capable of generating structured protocol information. Our customers can rest assured that their operational data and metadata,including audit trail,will be accessible using standards-based protocols,and that Medidata products will be interoperable with all other components in their clinical IT ecosystem that adhere to these standards.This interoperability can be directly translated to saved time and money. For our past three NDA submissions, we had one in-house CRT expert whom we relied on to generate and assemble all the relevant documents that comprised the CRT. Submission consisting of a main study, a few supporting studies and an integrated summary of safety (ISS). One of the reasons he was chosen to do this work was that he had a technical expertise that was not used on a day-to-day basis.
A lull in our submission schedule coincided with the new requirements of the electronic Common Technical Document (eCTD) submission format to set the stage for us to re-examine how we assemble CRTs and to consider what we can do differently The authors were tasked with developing a process to streamline and optimize the assembly of the CRT documents for inclusion in an eCTD submission.
CDISC – In 2003, CDISC started constructing a Domain Analysis Model to support harmonization of their models as well as with HL7. In early 2005, the BRIDG model was been adopted by the HL7 RCRIM Technical Committee as the RCRIM Domain Analysis Model and is being implemented at NCI.
The BRIDG Model serves to bridge standards, as well as organizations and various communities, including academic research institutions and pharmaceutical product development organizations and related service and technology providers.
To meet this need, the BRIDG SCC is starting an informal group of domain experts with various areas of expertise to whom we could direct questions on an as-needed basis. We will only contact members of this group who have the expertise related to the subject in question and the members don’t need experience in modeling.
The CDASH v1.1 Standard defines many of the basic safety collection fields found in the E2B. The electronic Common Technical Document (e-CTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information.
It was developed by the International Conference on Harmonization (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG).
Common Technical Document assemble all the Quality, Safety and Efficacy information in a common format (called CTD – Common Technical Document ) has revolutionized the regulatory review processes, led to harmonized electronic submission that, in turn, enabled implementation of good review practices.
The e-CTD is a message specification for the transfer of files and metadata from a submitter to a receiver. LOGYCLI  an innovative pharmaceutical company faced with meeting strict requirements for Electronic Common Technical Document (e-CTD) submissions as a hurdle to bringing new drugs to market. On average, a pharmaceutical company loses a million dollars every day that a new blockbuster drug is not released to the market. Yet the traditional publishing process pharmaceutical companies use to create e-CTD submissions only hinders the introduction of new drugs to the market because it relies on slow, error-prone manual techniques.
Using Quark XML Author for Microsoft Word, with little or no training anyone can create structured, reusable XML content in the familiar Word environment — content that can be automatically assembled and published following e-CTD submission guidelines. By creating structured XML content in Microsoft Word, you can automatically assemble reusable content components into documents to speed up the e-CTD submission process. You can take costs out of new drug development by streamlining the content creation, review, and FDA submission processes — which also improves the downstream publishing process.
The Anatomical Therapeutic Chemical (ATC) Classification System is used for the classification of drugs. As an innovation company, LOGYCLI continues to be focused on the discovery and translation of novel molecules into products that create value for patients and shareholders. LOGYCLI is a clinical-stage private company developing novel therapies to address unmet needs in psychiatry and neurology based on a new mechanism of action for modulating the NMDA receptor.
Clinical data management is involved in ensuring data quality and integrity is issued through the final statistical analysis of the resultant data. Identify data processing errors, correct such errors, and provide feedback after completion of a study. We have developed a user-friendly, simple, and needle-free transdermal delivery system consisting of a patch and applicator – that is proven capable of delivering a broad range of compounds, including peptides, proteins, small molecules and vaccines.
He or she will lead activities associated with the evaluation, initiation, and management of clinical studies ensuring compliance, managing timelines, budgets and review of all clinical data. We are highly responsive and provide customized services, which can be deployed on a stand alone basis or as part of an integrated “full-service” solution.
Reach out to Transpirus for practical home care and hospice solutions with measureable results.
Our proven assessment process focuses on identifying opportunities to streamline workflow, establish appropriate staffing ratios and eliminate redundancies while improving quality and financial performance.. Our models and recommendations are based on real world experience and proven implementation practices.
From complete compliance program oversight and outsourced coding services to periodic clinical, billing or coding audits to recommendations for continuous improvement Transpirus can help.
Led by an experienced home health master’s prepared nurse who holds HCS-D and COS designations, in collaboration with a team of RN Certified Coders, our approach partners with you to ensure supportive clinical documentation and timely, compliant coding.
From evaluation of level of compliance to potential RAC risk, utilization strategies, coding accuracy and quality of documentation, LOGYCLI can help. Sellers engage us to identify opportunities to improve operations, leverage strengths and mitigate risk under stringent due diligence processes. Often agencies don’t have the time, resources or expertise to invest in clinician training needed to ensure long term agency success. We employ these standards to enable efficient review, processing transmissions and submission of data to the regulatory authorities. At LOGYCLI, we’ve made the collection and handling of clinical trial data a central part of our entire service offering. Our global staff uses our well-documented processes and service levels agreements to ensure timely deliverables. Our clinical data management team produces results that are source-verified, reproducible and cost-efficient. Our internal expertise allows us to offer deeper insight by going beyond the standard automated checks and providing optional guidance in interpretation and correction of data compliance issues. Deliverable to client includes a prioritized list of issues identified during enhanced validation. Once datasets are validated, LOGYCLI’s expert consultants work with the client to resolve issues and refine processes. Competitive offerings require high-priced software license fees or rely on error-prone, manual checks. Pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. However, the regulatory requirements have become increasingly complex in recent years and expert knowledge is needed to fulfill the stringent obligations. Our global drug safety database helps you to track process and report adverse events in your client specific database instance. Although imaging of removed organs and tissues can be performed for medical reasons, such procedures are not usually referred to as medical imaging, but rather are a part of pathology. We are known for our medical, technology and regulatory expertise as well as our emphasis on imaging compliance and validation – key areas that require knowledge and expertise. Our therapeutic and imaging experts provide a range of capabilities in the application of imaging techniques from early clinical development through peri-approval studies. Our in-house therapeutic and imaging experts have the knowledge and expertise to develop a well-defined, objective review process. It maintains and manages the planning, preparation, performance, and reporting of clinical trials, with emphasis on keeping up-to-date contact information for participants and tracking deadlines and milestones such as those for regulatory approval or the issue of progress reports. Our team of Clinical professionals consists of highly experienced, trained, and dedicated Clinical Program Managers, Clinical Study Managers, and Clinical Research Associates committed to quality and compliance.
In particular, clinical trial operations represent one of the most resource-intensive areas within a biopharmaceutical company and often involve tedious, manual processes for collecting, aggregating and rationalizing information from a wide variety of data sources. By providing a single, centralized system to orchestrate operational and administrative activities, a CTMS allows biopharmaceutical companies and CROs to intelligently manage the complexities of clinical trials. With LOGYCLI CTMS, you will benefit from its global capabilities, adaptive framework and exceptional breadth of functionality.
The team draws on extensive experience from implementing and upgrading LOGYCLI CTMS for over 15 years for many biopharmaceutical and CRO clients. Our experts can build integrations with key clinical systems as well as perform data migrations for legacy data.
CDISC standards define the data structures within the clinical database management system, case report tabulations and analysis datasets.
Through our acquisition of Octagon, LOGYCLI has broadened its CDISC capabilities and market presence.
Unlike providers that just implement conversion and appear to lower costs per converted study, LOGYCLI’s proven process delivers high quality outcomes while driving down costs. Our analytical processes and tools allow us to work independently, efficiently and globally. The Submission Data Standards team of Clinical Data Interchange Standards Consortium (CDISC) defines SDTM. Each observation can be described by a series of variables, corresponding to a row in a dataset or table.
For instance, conversion of clinical database may be difficult due to the large number of CDISC domains and variables. The efficiencies are realized through the consumption of metadata that can automate processes that were previously more labor-intensive, while the consistency is gained in having the processes from across the clinical data lifecycle execute upon centrally managed metadata. It is still very common for metadata to be stored and managed in what has been labeled as a first generation metadata repository .Excel spreadsheets. Pressure is mounting from regulatory agencies for pharmaceutical companies to standardize—and fast.
We are able to advise and provide services in relation to data integration and data conversion of data to SDTM and ADaM formats. Our CDISC working group has experts that are actively involved in CDISC User Groups and that ensure all programmers have been trained in CDISC.
The combination of SDTM data and calculated derived data in a format which is one procedure away from the final statistical results is under complete control by our LOGYCLI experts. Our team of professionals reliably ensures consistency between the distinct trials of your product development, from early phase to the final submission. The necessity of a solid SDTM product as a base for ADaM is strongly encouraged in the interaction between LOGYCLI and our clients.
The metadata fits perfectly with the data and allows the regulatory reviewer or statistical counterpart at the client to follow the path from source data to the final statistical results This documentation can be used together with the statistical analysis plan to verify the correctness of complex efficacy calculations and model compositions.
Especially with repeat business, LOGYCLI has proven to deliver the best services in long term cooperation with many clients. Sponsors can however now design the whole study design using a user-friendly design tool that exports its results in CDISC ODM format. The great advantage is that all the advantages of using the ODM are maintained, and that the instance ODM documents with data for these features can easily be validated against the schema (and the ODM standard) without the need for special software. We had confidence in his technical prowess and were uncertain how we would replace these skills if he were to move on. Our resulting process automates the technical aspects of the CRT build and presents a series of steps that any primary programmer can follow and use. CDASH v1.1 identifies the basic data collection fields needed from a clinical, scientific and regulatory perspective to enable more efficient and consistent data collection at the investigative sites. This CDASH SAE Standard contains a subset of variables that sponsors should complement with variables found in CDASH v1.1. For industries, it has eliminated the need to reformat the information for submission to the different ICH regulatory authorities.
Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions. It helps to streamline the creation, assembly, review, and submission process for both new and generic drugs.

And because enormous costs are required to develop new drugs over an average of 10-15 years, anything that can speed up the process is paramount. Pharmaceutical companies can streamline and automate the way they create, review, and publish information to speed up the submission process and bring new drugs to market faster.
This speeds up the entire submission process, delivers more accurate content, and can contribute to the faster introduction of new drugs to the market. It is controlled by the WHO Collaborating Centre for Drug Statistics Methodology (WHOCC), and was first published in 1976. Each bottom-level ATC code stands for a pharmaceutically used substance, or a combination of substances, in a single indication (or use). Naurex’s 1st-generation drug candidate, GLYX-13, has shown robust and rapid antidepressant activity with excellent safety in a Phase IIa study in subjects who had failed treatment with current agents. This innovative technology is enabling us to develop products with significant commercial potential both independently and in collaboration with strategic partners.
The Associate Director, Clinical Operations will serve as the primary contact for the contract research organizations (CROs), laboratory vendors and clinical sites involved in the clinical trials. These services can support both global and locally managed projects.We believe in managing our client relationships as strongly as we manage our studies.
Transpirus’ experienced team traces workflow from referral to cash posting and provides practical, real world solutions for improved efficiencies and cost effectiveness. The LOGYCLI team not only has the expertise for workforce design, but can apply our proven project management skills for effective delivery of staff model implementation and change management. From end-to-end outsource solutions to periodic audits, trend analysis and staff education, LOGYCLI provides the hospice and home health support you need to ensure appropriate reimbursement, preserve revenue and minimize risk. Our goal is to help you identify areas of potential vulnerability, improve staff education, promote better home care compare outcomes, obtain appropriate reimbursement and mitigate risk.
Sound business decisions can only be made when all facts and data are analyzed and validated. What your staff doesn’t know CAN hurt you in terms of reimbursement, quality reporting and compliance with Medicare Conditions of Participation.
Our expert certified resources work with customers internally and externally to ensure each trial is developed to the highest standards using the latest technologies available in the marketplace.
We continue to build an impressive portfolio of experience is the use of the various CDISC models including SDTM and ADaM.
LOGYCLI, CDM team leaders have more than 12 years of experience, on average, and a background in medicine or biological sciences.
Checkpoint combines Octagon’s practical knowledge of CDISC SDTM with automating technology to provide a cost effective alternative.
Information received from patients and healthcare providers, as well as other sources such as the medical literature, plays a critical role in providing the data necessary for Pharmacovigilance to take place. This has led to increased safety data collection, analysis and regulatory surveillance, which in turn has increased costs. LOGYCLI Pharmacovigilance team is comprised of Medical & healthcare professionals with vast experience in both direct patient care and industry-specific Pharmacovigilance services, which enables us to provide you with the highest quality safety surveillance services. We can support you in building your own in-house Pharmacovigilance program (PV database implementation and validation). Our clients are advancing clinical research through the strategic use of our significant experience in novel modalities to provide results that accelerate early decisions about therapeutic agents and decrease time and cost associated with clinical development. By helpingcustomers maximize the value ofintegrated technologies, we are able to deliver superior dataquality, simplify user workflows and expedite the trial process.
LOGYCLI team brings a depth of experience in a broad range of therapeutic areas and a profound understanding of ICH, GCP, and FDA regulatory requirements to ensure the highest quality throughout all phases of development. Instead of relying on disparate “islands” of information, often in direct conflict with each other, CTMS users benefit from sharing consistent trial data across the entire enterprise. Our tried and tested methodology and consultative approach help guide clients through the implementation process ensuring that the system is delivered in a way that aligns with client objectives. Our consultants are well-versed with data exchanges with other clinical trial technologies including EDC, RTSM (Randomization and Trial Supply Management), financial and proprietary CRO systems. CDISC standards are employed as a service by many organizations as it brings clarity and simplicity to the clinical data which is now far more organized than before after CDISC standards implementation. These standards affect several operative functions where clinical data has to be handled or is handled.
Our experience and insight allow pharmaceutical companies to accelerate the conversion process, reduce rework, and design technology and processes to be faster and less expensively. As a result, clinical and nonclinical Data Managers will need to become proficient in the SDTM to prepare submissions and apply the SDTM structures, where appropriate, for operational data management. Similarly, there may be errors and delays in data conversion as many ETL (Extract, Transform, Load) programmers lack the CDISC domain expertise.
Additionally, the Center for Drug Evaluation and Research (CDER) also encourages its use for ensuring efficient and quality reviews.
While this tool does provide a favorable comfort level to clinical staff, it is limited with regards to the operational maintenance, elemental-level versioning, and effective utilization.
Most derivations were done on the fly in the analysis programs creating the tables, figures and listings. Based on collaboration with clients in a wide range of therapeutic areas LOGYCLI is in a strong position to deliver complete CDISC compliant ADaM products within accomplished successful registrations. The high level of quality is obtained by use of extensive software developed in-house at Logycli, ensuring compliance and consistency. This ODM file can be send to the EDC vendor, allowing the latter to set up the whole EDC system including the creation of eCRFs in a matter of minutes. Review starts with the Define document which Contains metadata describing the datasets, variables, and values. Not having worked intimately on the project until this point, he would have to start from scratch to learn each study– reconstructing specific algorithms and other calculated variable definitions from e-mails, spreadsheets, and other assorted documents. After he left the company, one of the primary tasks of interest for us was to automate the technical aspects of the CRT assembly and create a new process that any primary programmer could do.
This paper documents the results of the project and outlines the process that we developed. We have intentionally not reproduced the entire CDASH standard but have included existing CDASH variables that map to safety reporting data elements, where appropriate. Food and Drug Administration announced that the e–CTD is the preferred format for electronic submissions.
In July 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to the FDA.
Whether you work for a biotech, an Academic institution, or a financial organization, we welcome the opportunity to discuss our shared interests and how we can work together.
A single intravenous administration produced statistically significant reductions in depression scores within 24 hours that persisted for an average of seven days. Our project teams develop integrated plans involving all stakeholders in the organizations, from project staff to senior management, to ensure that the business relationship succeeds. Count on LOGYCLI to identify clinical strengths, weaknesses, opportunities and risks associated with your targeted investment or acquisition.
LOGYCLI provides on-site facilitated and web based training to educate agency staff on best practices for home health and hospice. Each has experience in multiple therapeutic areas and in handling data needs for local, regional and global trials.
In fact, in order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder (usually a pharmaceutical company) must be submitted to the local drug regulatory authority.
You, therefore, need a strategic partner with process expertise–one who can minimize your cost pressures while unlocking value and maintaining compliance. This allows the sponsor organization to streamline processes, appropriately respond to current statuses and proactively manage their trials.
Customers can also choose to implement LOGYCLI CTMS as an on-premise solution and install within their operating environment.
In addition, we have served as a trainer for the FDA, and we actively participate in CDISC initiatives and co-author CDISC standards. We help clients meet both their conversion objectives and their larger business objectives. A Role determines the type of information conveyed by the variable about each distinct observation and how it can be used. It has become a CDISC regulated content standard that describes how to organize subject information into variables and domains to be used as a standardized submission dataset format.
The converted data would also result in multiple lines of code that is difficult to understand and re-use. The standard has improved data management, data integrity checking, data and cross-study analysis, as well as reporting.
It is all tied together using internal and External hyperlinks, bookmarks, and destinations to make it easily navigable. He also required frequent meetings with the primary programmer for each study to pick their brain on what to document, why a particular algorithm, whether variable definitions for the addendum were correct, and numerous others study details.
To date, over 98,000 e-CTD sequences have been submitted to the FDA. Although the agency has not released an expected target date, the FDA revealed during the 2009 DIA Annual Meeting that it is looking at draft legislation to require e-CTD. On the other hand, several different brands share the same code if they have the same active substance and indications. Our lofty goals are built upon the resourcefulness, talent, insight, and drive of our employees. The right candidate will have the depth of clinical research experience and regulatory knowledge necessary to make independent operational decisions and be comfortable in executing daily operational tasks. Ownership and accountability are at the core of communication plans, which provide transparency and understanding throughout the process.We place the highest importance on delivering quality data on time and on budget. From OASIS Assessment Strategies to Compliance, Coding and Care Coordination, our skilled training team can support staff education. Product modules cover the management of trial progress, planning, monitoring activities, supplies and finance. The purpose of this model is to structure and format the tabulation data that are to be submitted to a regulatory authority. In addition, every sponsor company implements SDTM with some variation, because the model is subject to interpretation and allows some flexibility.
The widespread acceptance of SDTM will be beneficial for both the industry and the regulators in terms of efficient data conversion process and reduced related cost. Additional data fields may need to be added to address study-specific and therapeutic area requirements, and applicable regulatory and business practices. From start-up to completion, performance is monitored regularly and measured against contractual timelines. In order to help you sustain results achieved through front line training, our team provides on-site coaching and mentoring to advance Clinical Management and Agency Director effectiveness.
SDTM is based on the concept of observations (described by variables) made on the subjects who participate in a clinical study. Therefore, additional documentation like the ‘Define’ (metadata definitions) document is required to support the data sets. Since a number of the CDASH v1.1 variables are optional, an assessment should be made of whether or not they were included on the study form or if they need to be collected for the distinct purpose of having the data to report in an E2B safety report.
This commitment provides the basis for a productive and collaborative effort, promotes personal and professional growth, and helps to ensure our continued success. In addition, project costs are tracked to ensure adherence to agreed budgets.In an increasingly challenging environment, we have the experience and knowledge to ?nd, recruit, and retain patients in clinical trials.
Moreover, the SDTM standard is an evolving one and new guidance updates may affect submissions and involve restructuring of data. When the data are identical between the two standards, the SDTMIG variable names are presented in the CDASH domain tables. We are seeking individuals who want to make a mark in their profession and who are eager to grow.
We successfully deliver access to appropriate sites and patients, developing strategies that will minimize the risks inherent in patient recruitment. The key idea of this model is that the domains are divided into Findings, Interventions, Events, and Special Purpose classes.
In cases where the data are not identical or do not exist in the SDTMIG, CDASH has suggested new variable names.

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