Why Pharmacovigilance is important in Clinical Trials?admin
Pharma companies produce the medicines to ease the pain of living beings on earth. Based on the medical solution that is required by the ones in pain, these companies use their trial population to conduct clinical research. India is one of the leading service providers of clinical research services in the world.
To ensure the safety of drugs for patients, pharmacovigilance services are utilised by the pharma companies in clinical trials for drug development. Here are some of the key reasons why pharmacovigilance services in India are important for clinical trials:
- Safety Of Trial Participants
Clinical trials are conducted to determine the efficacy of a drug. And safety is the utmost concern for every clinical trial operation. Pharmacovigilance services support the project team to adhere to safety standards that protects the identity and well-being of the trial participants.
Stringent laws are present across the world to ensure safety in clinical trials. But ethical companies hire reliable support services to follow these laws as well as to encourage a fair trial for drug development.
- Manage SAE
Safety Adverse Events (SAE) Reporting can be a time-consuming process but it is necessary as per regulatory authorities in many countries. These reports are created by pharmacovigilance companies by collating data from various sources such as trial participants, regulatory resources, media reports, and other literature.
- Risk Benefit Profile
The Adverse Event Reporting process also helps authorities and project sponsors to determine the risks and benefits involved in producing a drug. Clinical research professionals create a risk profile of the drug which includes its harmful effects, precautions for consumption, warnings etc. The benefits profile will list the therapeutic benefits of the drugs on the clinical trial population.
The risk benefit profile gives a clear picture of whether the risks outweigh the benefits or not. This profiling includes details of the trial participants, their response to the drugs, etc. Regulatory authorities look for a positive risk benefit profile with a balance between risks and benefits as per the guidelines.
- Maintain Safety Records
Pharmacovigilance services in India are undertaken by well-qualified and experienced clinical research professionals. They not only help you to maintain safety records of all the small and big safety incidents but also help you in preventing similar safety lapses through insightful reports.
Case Safety Reports (CSR) are reports covering the adversity faced by each individual who was part of the trial as a participant. After the relevant data is used for the existing project, these reports are archived for future projects.
- Project-specific Safety Approach
Every project is different in clinical research. India offers reputed CROs who deliver customised pharmacovigilance services. These services are designed taking in to consideration the project scope components such as project location, project team, participants, timelines, processes and so on.
Safety Adverse Events reporting is a critical step in drug development. Authorities study SAE reports and other drug development documents carefully. Service providers assist project sponsors by collating all the necessary documents that is to be sent for drug evaluation by authorities. And finally, the evaluation process will lead to the acceptance or rejection of the drug which will determine whether drug will be produced for the masses or send back to the lab for further research.
To conclude, pharmacovigilance services in India by reputed service providers such as BiosphereCRO, are a great help to conduct successful clinical research. Their expertise and understanding of the drug development process makes it easier for pharma companies to roll out useful drugs in the safest possible manner.