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Risk Management in Clinical Trials

Clinical trials are more like innovations in drug therapy and perhaps even more important if they synonymously mean life-saving. Thus, a clinical trial is complex and has much at stake. It has financial, regulatory, and operational risks, both for sponsor organizations that fund and monitor the trials as well as themselves. In short, it is called risk management for sponsors, which is vital because they have invested lots of money. Sub-investigator is an example of one such activity in this vast intricate process.

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Risk Management in Clinical Trials

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  1. Risk Management in Clinical TrialS

  2. Introduction Clinical trials are more like innovations in drug therapy and perhaps even more important if they synonymously mean life-saving. Thus, a clinical trial is complex and has much at stake. It has financial, regulatory, and operational risks, both for sponsor organizations that fund and monitor the trials as well as themselves. In short, it is called risk management for sponsors, which is vital because they have invested lots of money. Sub-investigator is an example of one such activity in this vast intricate process.

  3. Understanding Clinical Trial Risks • Financial Risks: Clinical trials are financially intensive: from participant recruitment to management of clinical trial sites. • Regulatory Risks: These are risks of not being compliant to stiff regulatory requirements. Stiffness can get the trial suspended, fined, or get the disqualification of the drug/treatment under investigation. • Operational Risks: This involves participant recruitment, protocol deviations, and data integrity issues. • Reputational Risks: Any misdeed involving the clinical trial data or ethical violations can ruin the integrity of the sponsor and subsequently affect any future partnerships they may develop or any investment they may attract.

  4. Who Are Sub-Investigators? Sub-investigators are critical members of the clinical trial team that function with and under the authority of the principal investigator (PI). While the PI is concerned with the overall conduct of the study, the sub-investigators attend more to such details as patient care, data collection, and protocol compliance. Their unique expertise ensures the appropriate flow of the trial and conduct according to all regulatory and ethical standards.

  5. The Sub-Investigator's Role in Risk Management • Ensuring Protocol Adherence • Maintaining Data Integrity • Participant Safety and Retention • Regulatory Compliance • Risk Assessment and Mitigation

  6. Leveraging Technology for Effective Risk Management • Clinical Trial Databases • Clinical Trial Platforms • Clinical Trial Data Management • Clinical Trial Search Tools

  7. Conclusion Risk management in clinical trials is paramount, with the sub-investigator's role in counterbalancing these risks being extremely critical. These encompass adherence to protocols, data integrity, participant safety, and regulatory compliance, all contributing toward safeguarding sponsor investments.

  8. Website: www.clival.com Location:- C-89, Sector-65 Noida-U.P. 201301 (India) E-Mail:- info@lifescienceintellipedia.com | sales@lifescienceintellipedia.com Phone:- +91-120-6631301-335 Mob No:- +91-9990237670

  9. THANK YOU

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