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How pharma data / business analytics are helping pharmaceutical companies?

Case Study: A top pharmaceutical company was interested to develop a medicine for diabetes, and for which it wanted to asses and identify attractive patient segments. Approach: Secondary research was undertaken to understand current diabetes treatment guidelines and therapy landscape, to identify patient segments. Following this trial analysis was undertaken to identify upcoming trends and molecules in different patient segments of diabetes. The molecules and trends were further analyzed to ascertain their expected relevance on the diabetes landscape through clinical data and benchmark analysis. Key trends analyzed during the study were related to epidemiology, pricing, regulatory activities, and market access regulations across geographies. These findings were further validated through an intense primary research involving key opinion leaders, payers, physicians and regulatory bodies. The all inputs from primary and secondary research with collated together and analytical tools, such as…
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Proactive pharmacovigilance through Social media data

Proactive pharmacovigilance through  Social media data
Adverse drug events (ADEs) are a significant cause of morbidity and mortality worldwide. Clinical drug trials have limited ability to detect all ADRs due to various reasons: small sample sizes, relatively short durations, lack of diversity among participants usually excludes specific conditions: kids, elderly, pregnant women, patients with co-morbidities. Pharmacovigilance practice has evolved and grown more complex over the past 5 to 10 years due to higher data volumes, evolving regulations, increased influence of emerging markets and the emergence of social media and innovative technological advances. Social media is a promising source for new safety data and potential emergent safety signals.
Social media may be a method by which pharmacovigilance could be strengthened given that approximately 72% of internet users search for health information online. Social media have significantly expanded recently with Twitter and Facebook now…

FOR HEALTHY US

FOR HEALTHY US The ever changing environment and day to day stress starting from the childhood for securing higher grades leading up to the never ending demands of the boss pushing for more. Everyone today is either already been affected by some or the other type of medical condition or is at the high risk of developing one. 

The major sufferer is the health of an individual, which affects the individual’s quality of life and hampers the growth of the nation too. But thanks to the professionals involved in the health services that we are constantly able to manage our health and stay fit. Clinical Research plays an important role in offering us the solutions to our health challenges with safe drugs and devices. 
Scientists conduct Clinical trials, a research study that tests how well an intervention works in a group of people. It tests for new methods of screening, prevention, diagnosis or therapy. Clinical trials are conducted in different phases, ADR Reporting during which additiona…

ZINBRYTA to face restrictions on use, following a safety review by EMA showing serious liver damage

Multiple sclerosis (MS) is condition in which the immune system attacks myelin sheath, which may eventually damage the neurons and leave scar tissue, relapsing multiple sclerosis is a type of sclerosis in which there is flare up following remission, which means during the relapsing phase, the symptoms of MS will partially or completely go away. 
daclizumab is a type of Interleukin 2 receptor (IL2R) antagonist which is used in the treatment of MS. (Interleukin is a type of Cytokine which binds with IL2R to generate immune responses, a type cell signalling) daclizumab was administered as an injection under brand ZINBRYTA, which was first approved by FDA on 27th May 2016, however recently the Pharmacovigilance Risk Assessment committee (PRAC), a part of European Medical Agency recommended restrictions on using daclizumab, due to safety issues associated with serious liver damage (as reported in a clinical trial where 1.7 % subjects developed serious liver reaction, a suspected unexpected …

Why is E2B Validation important?

In Pharmacovigilance -Case processing after completing the data entry process and before routing the case to the next workflow (Medical Review), it is mandatory for everyone to do a Validation check called as E2B validation, E2B validation error could also be an error associated with a special character in case study narrative or in adverse event, further if an error is reported on Validation check which cannot be rectified, a comment stating ‘E2B validation was noted and bypassed’ should be used contact log
Every wondered why?
Every ICSR (Individual case safety report) as per 21 CFR 314.80 in US and Schedule Y appendix XI in India, should be transmitted from the reporting sources to the regulatory authority and this process is also known as E2B submission (as we submitting E2B files) and because one of the mode of transmission is via XML format, if a special character found in the ICSR which is not rectified after the ICSR is converted into an XML file and upload as an E2B file in th…

Vank's disease: A compelling need to decrease Anti Tubercular (TB) drug resistance

Tuberculosis is an infectious and contagious disease caused by a bacteria called Mycobacterium tuberculosis. Tuberculosis primarily affects the lungs, symptoms include: chronic cough with blood in Phlegm, fever.

Pharmacovigilance imparts a vital role in monitoring serious Adverse drug reactions (ADRs) in TB patients who are on treatment in national TB program.
ADRs could lead to a tuberculosis (TB) patient interrupting treatment before completion, and can thus contribute to avoidable morbidity, drug-resistance, treatment failure, reduced quality of life, or death.
Tuberculosis is completely curable using short term chemotherapy called DOTS or Directly Observed Treatment Short course. However, there are several challenges encountered by patient to get DOTS treatment in India. Some of the challenges include coping up with DOTS strategy. In a recent research paper published by (research, team name), it had a study which in which TB patients were interviewed, the paper says ‘Poor patients…

Pharmacovigilance system- Industry perspective, Market size and Operations

Monitoring adverse drug reaction is an essential component in patient safety. In the last decade we have seen how technology has influenced the entire healthcare system, leading to patient awareness, thus making the pharmaceutical companies and regulatory authorities to invest more time and resource in monitoring adverse events.
Pharmacovigilance as per WHO is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem Pharmacovigilance is the study of adverse events taking into account all the plausible relationship or untoward medical occurrence which the patent experienced after taking the drug and then using standard set of coordinated activities which involves first collecting adverse event reports either via telephone, email, social network, lay press , media. After adverse event reports are filed we then process and assess these reports in database to determine if indeed these adv…