We are glad to say that BioSpectrum Magazine highlighted the name of BioMed Informatics, for its predominant role in the emerging technologies of Pharmacovigilance and Clinical Data Management.
The study design that provides the most compelling evidence of a causal relationship between the treatment and the effect, is the randomized controlled trial. Currently some Phase II and most Phase III drug trials are designed to be randomized, double-blind, and placebo-controlled. While the term clinical trials is most commonly associated with large randomized studies, many clinical trials are small. Often the centres taking part in such trials are in different countries (in which case they may be termed international clinical trials). The number of patients enrolled in the study also has a large bearing on the ability of the trial to reliably detect an effect of a treatment. Pharmaceutical clinical trials are commonly classified into four phases, and the drug-development process will normally proceed through all four stages over many years.
There are two specific kinds of Phase I trials - SAD studies, and MAD studies.SAD - Single Ascending Dose studies are those in which groups of three or six patients are given a small dose of the drug and observed for a specific period of time. Once the initial safety of the therapy has been confirmed in Phase I trials, Phase II trials are performed on larger groups (100-300) and are designed to assess clinical efficacy of the therapy; as well as to continue Phase I assessments in a larger group of volunteers and patients. Phase III studies are large double-blind randomized controlled trials on large patient groups (1000-3000 or more) and are aimed at being the definitive assessment of the efficacy of the new therapy, especially in comparison with currently available alternatives. Phase IV trials involve the post-launch safety surveillance and ongoing technical support of a drug. Pharmacovigilance is a discipline which is concerned with identifying, validating, quantifying, evaluating and minimizing the adverse effects of medicine thereby increasing the safety of drugs in use. Pharmacovigilance plays an important role in the use of medicines by providing information about ADRs in the general population. Pharamcovigilance improves patient care and safety in relation to the use of medicines and all medical and paramedical interventions.
Oracle Argus Safety is an advanced and comprehensive adverse events (AE) management system that helps life sciences companies enable regulatory compliance, drive product stewardship, and integrate safety and risk management into one comprehensive platform. CDM (Clinical Data Management) is used in clinical research to manage the data of a clinical trial. A new blockbuster drug takes around $850 million to be developed by an international giant. The most commonly performed clinical trials evaluate new drugs, medical devices, biologics, or other interventions to patients in strictly scientifically controlled settings, and are required for regulatory authority (in the USA, the Food and Drug Administration) approval of new therapies.
Maintaining and verifying the clinical data like patient demographics, adverse events, laboratory, medical history, suspects, concomitant medications from source documents, etc. Statistical analysis plays a predominant role in finding the safety and efficacy of a drug in Clinical Research.
Anne, a consultant geriatrician and Honorary Clinical Associate Professor at the University of Glasgow, holds a portfolio post with the Scottish Government and Joint Improvement Team as clinical lead for Integrated Care.
Anne is passionate about support and care that are citizen led, fully integrate health, social care, housing, community and voluntary sectors, and are co-designed and delivered with enterprise and academic partners. Ranald is Chief Executive of Scottish Care, the representative body for private and voluntary Care Homes, Care at Home and Housing Support services in Scotland. Ellen is currently the Associate Director, Professional Practice for the Royal College of Nursing, Scotland.
Niki Maclean joined the SPSO in August 2005, taking on the role of Director in 2010 where she has responsibility for operational delivery. Prior to the SPSO, Niki worked as an HR professional, and has 12 years' experience within the fields of HR and organisation development across the public and private sectors including the teaching, health, legal and accountancy professions. Jacqui Pentland is a Research Practitioner from the Firefly Research Team (led by Professor Kirsty Forsyth) at Queen Margaret University, Edinburgh. In 2013 Jacqui completed an MSc degree in Occupational Therapy based on her resilience research and recently gained a place on the Professional Doctorate course at QMU.
Rosemary has worked within the Scottish Court for 40 plus years as both a technician and a manager. Claire has worked for Audit Scotland for ten years and is responsible for national audits of performance in primary and community care and housing. Lynn Williams moved to SCVO in May 2012 following almost three years lobbying to improve the lives of Scotland’s carers at The Princess Royal Trust for Carers.
Valerie works for Snook, an award-winning service design agency with offices in Glasgow and London. Sue has an extensive professional health background in nursing, midwifery and public health. Duncan MacLennan was great as ever, bringing a very interesting perspective to the challenges (and failings) of housing.

Studies in epidemiology such as the cohort study and the case-control study are clinical studies in that they involve human participants, but provide less compelling evidence than the randomized controlled trial. This means that each study subject is randomly assigned to receive one of the treatments, which might be the placebo. If the drug successfully passes through the first three phases, it will usually be successfully approved for use in the general population.
If they do not exhibit any adverse side effects, a new group of patients is then given a higher dose.
In these studies, a group of patients receives a low dose of the drug and the dose is subsequently escalated upto a predetermined level.
The development process for a new drug commonly fails during Phase II trials due to the discovery of poor efficacy or toxic effects. Phase IV studies may be mandated by regulatory authorities or may be undertaken by the sponsoring company for competitive or other reasons.
It is a study of drug related adverse effect carried out by pharmaceutical industries to suggest warnings and recommendation for product withdrawal. It also contributes to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging safety and more effective use. Argus Safety is industry-proven and accepted, having been used for more than a decade at leading Pharmaceutical, Biotech, CRO, and IT Companies. The clinical trial data gathered at the investigator site in the case report forms are stored in CDMS. Globally most of the Companies representing IT, Pharmaceutical, Biotechnology, SMO and Contract Research Organizations (CRO) have relied on Oracle Clinical to conduct Clinical Trials, making it the market-leading Clinical Research solution providing highly paid Oracle Clinical Jobs in India, USA, UK, as well as other countries. Trials may be designed to assess the safety and efficacy of an experimental therapy, to assess whether the new intervention is better than standard therapy, or to compare the efficacy of two standard or marketed interventions.
She leads work to transform care and support for older people and people with Multimorbidity in Scotland, participates in the European Innovation Partnership on Active and Healthy Ageing and supports the implementation of the National Delivery Plan for Telehealth and Telecare. Prior to coming to Scottish Care in 2007, Ranald had an extensive career in Social Work and Social Care across a range of settings. She is responsible for leading the professional arm of the RCN which includes managing and supporting the learning & development, knowledge and research and policy functions within RCN Scotland. Her focus at the SPSO has been on continuously improving the efficiency and effectiveness of its service in order to support improvement within the many public services SPSO interacts with. The Firefly Research Team collaborate with service users, practitioners and managers from health, social care and the voluntary sector to deliver evidence into practice and generate evidence for practice.
She holds a diploma in Management and Leadership from the Chartered Management Institute and was delighted to be a finalist at the NHS Allied Health Professional Advancing Healthcare Awards in 2013. Previously he was a consultant in old age psychiatry, national clinical lead for dementia with the Scottish Government and clinical advisor to the older people in acute care programme at Healthcare Improvement Scotland.
She has been with the Office of Accountant of Court for the last 15 years - being involved in the management of the old Curatory cases prior to the implementation of the Adults with Incapacity (Scotland) Act 2000.
She has led on reviews of mental health, drugs and alcohol, the major pay contracts in the NHS, Community Health Partnerships and transport for health and social care. Previously, Lynn worked for Careers Scotland and Skills Development Scotland with a wide portfolio including equality, operational planning, and staff engagement in planning for service delivery. She is an experienced service designer who focuses mostly on co-designing health and social care services, improving both the experience of the citizen and the efficiency and effectiveness of the service delivery. During her career she has held a diverse range of posts from Head of Midwifery to leading on service redesign for cancer and palliative care services across hospital and community settings. She has held a number of posts including Development Manager, Healthcare Manager, Complaints and Quality Assurance Manager and Inspection Programme Manager North area, prior to being appointed to Depute Director of Inspection, Adult Services at the Care Inspectorate.
Ashok IAS, Director of Biotechnology, Government of Andhra Pradesh, highlighted BioMed Informatics, in his interview with Pharmabiz Magazine in Mumbai. The major difference between clinical trials and epidemiological studies is that, in clinical trials, the investigators manipulate the administration of a new intervention and measure the effect of that manipulation, whereas epidemiological studies only observe associations (correlations) between the treatments experienced by participants and their health status or diseases. Neither the subjects nor scientists involved in the study know which study treatment is being administered to any given subject; and, in particular, none of those involved in the study know which subjects are being administered a placebo.
Other clinical trials require large numbers of participants followed over long periods of time, and the trial sponsor is more likely to be a commercial company or a government, or other academic, research body. It is usually expressed as the probability that, if the treatments differ in their effect on the outcome of interest, the statistical analysis of the trial data will detect that difference. Before pharmaceutical companies start clinical trials on drugs, extensive pre-clinical studies are conducted. This phase includes trials designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a therapy.
This is continued until intolerable side effects start showing up, at which point the drug is said to have reached the Maximum tolerated dose (MTD).

Samples (of blood, and other fluids) are collected at various time points and analyzed to understand how the drug is processed within the body. Post-launch safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and timescale than was possible during the initial clinical trials. Communicating the potential harm of drug-use to patients is a matter of high priority and should be carried out by every prescriber. CDM (Clinical Data Management) comprises of designing and deploying clinical study as well as collecting data and managing data for that clinical study. He completed his undergraduate degree at Stirling University and his professional training at Nottingham. She has been with the team at QMU since 2009, before which she worked as a community Occupational Therapist in Edinburgh. Before joining Audit Scotland Claire worked in acute and primary care trusts in the North East of England and for the Audit Commission. Lynn is an unpaid carer and continues to work in her own time to raise the issues affecting carers across Scotland.
She has a PhD in Healthcare Service Design and is motivated by creatively addressing the challenges associated with engaging patients and citizens in co-producing public services.
She also worked in the Middle East in the 1980s, modernising maternity services in this area. These trials are almost always conducted in an inpatient clinic, where the subject can be observed by full-time medical staff. Such adverse effects detected by Phase IV trials may result in the withdrawal or restriction of a drug. Information collected during the pre-marketing phase of drug development may not detect rare ADRs. Electronic Processes are used to plan, collect, access, exchange, manage and archive data for the purpose of reporting the entire clinical study data. It plays a major role in Clinical Research because data of Clinical Research are of a variable nature. He also has a Post Qualifying Award in Child Care Studies from Newcastle University and the Certificate in Social Services Management and Leadership from Robert Gordon’s. Prior to joining the RCN, Ellen was Head of Nursing for the Rehabilitation & Assessment Directorate in NHS Greater Glasgow and Clyde.
Jacqui is currently co-leading a research collaborative called Making it CLEAR- community living, enablement and resilience (MiC)’, alongside Professor Forsyth.
As one of two Deputy Public Guardians, Rosemary manages one of the multi-functional teams, the guardianship account review team and the investigation team which investigates complaints received regarding possible financial abuse of incapable adults. However, in designing a clinical trial, this consideration must be balanced with the greater costs associated with larger studies. Adoption of CDM to drive forward drug research is gaining pace, championed by the pharmaceutical industry, primary health providers, CRO industry & USFDA regulators. It is very difficult to draw a concrete conclusion from Clinical Research because of inherent differences between two individuals and also from group to group. The aim of MiC is to enable older people to live well within their communities by better understanding what supports them to remain resilient. The power of a trial is not a single, unique value; it estimates the ability of a trial to detect a difference of a particular size (or larger) between the treated and control groups.
Phase I trials also normally include dose-ranging studies such that doses for clinical use can be refined. Clinical trials generally enroll a selected, limited number of patients and may not include certain sections of the population. Ranald is also involved in a range of Scottish Government planning groups for services for Older People. The tested range of doses will usually be a small fraction of the dose that causes harm in animal testing. Interpretation, drawing conclusions and recommendations play a major role in Clinical Research. Therefore, Pharmacovigilance is needed for detecting ADRs and specifically to combat counterfeit and substandard quality products.

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