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Risk Benefit Profile in Clinical Trial- PR_13- 16 Nov. 2022 pdf - 29NOV

Risk and benefit profile which study sponsors and investigators can easily gather, assess, and report important information about the risks and benefits of a study to help participants make an informed decision about whether or not to enroll.

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Risk Benefit Profile in Clinical Trial- PR_13- 16 Nov. 2022 pdf - 29NOV

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  1. www.prorelixresearch.com

  2. Is there any Risks and benefits involved in producing a drug ? CRO CRO can assist for Clinical Trials 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. www.prorelixresearch.com

  3. Risk Benefit Profile Identifying Benefits and Risk Assessing Benefits and Risk Interpretation and Recommendation Expert judgment and communication 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. www.prorelixresearch.com

  4. Maintain Safety Records Pharmacovigilance services 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. www.prorelixresearch.com

  5. Sponsor has to maintain a detailed records. Case Study Report (CSR) Detailed analysis by sponsor on individual case study report . Collected adverse effect from all the participating sites. 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. www.prorelixresearch.com

  6. Project-specific Safety Approach Approach To Project Safety Visible For Safety Safety Culture Every project is different in clinical research. Many reputed CROs who deliver customised pharmacovigilance services which are designed taking in to consideration the project scope components such as project location, project team, participants, timelines, processes and so on. www.prorelixresearch.com

  7. 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. www.prorelixresearch.com

  8. ProRelix Research is here for the timely execution of your projects! www.prorelixresearch.com

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