Sentrx discusses the importance of outsourcing data monitoring to a sole entity.
Sentrx develops SOPs and work processes to ensure synergies exist between the sponsor and the Outsourcers regarding IRB or Data Monitoring, and believes that issue resolution in complex trials must be worked out rapidly and satisfactorily for the sponsor. Sentrx prides themselves on having developed mechanisms to do this.
Do you have Pharmacovigilance Synergy?
Would you hire a CRO to handle your IRB or Data Monitoring Committee responsibilities? Institutional Review Boards (IRBs), otherwise known as Ethical Review Boards/Ethics Committees, conduct the risk-benefit analysis to determine whether or not research on a compound is appropriate, sufficient safeguards are present to protect the patients and, during the course of the study, whether it should be continued. Data Monitoring Committees (DMC) Boards also monitor the study separately from the IRB. They are staffed by outside experts in the area of clinical research, pharmacovigilance and statistics. Each can approve, require study modifications, or recommend stopping research on a compound. They are designed to protect the rights and welfare of enrolled patients in clinical trials. These committees are dependent on the sponsor (who pays for them) and who often has a say in choosing the CRO and in constituting the DMC.
Why then is it appropriate to utilize a CRO to conduct these and other Pharmacovigilance operations?
Pharmacovigilance is the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines. This is performed through the collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological and medical devices, with the goal of identifying new information about hazards associated with medications, biological and medical devices and / or preventing harm to the patients. The results of such assessment are communicated to the IRBs and health authorities and have a high degree of influence over the IRB research continuation decision. Accordingly, Sentrx believes that it is in the best interest of the sponsor to maintain an arms-length distance from the committees and pharmacovigilance operations which maintains oversight of the whole program. This is particularly true if multiple CROs (on different continents) are involved in the study. In order to maintain arms length distance, sponsors should seriously consider pharmacovigilance outsourcing (PVO) with a single entity to ensure consistency in process and a single safety database across all trials and / or marketed products.
Sentrx believes that synergies between the sponsor and all of the organizations that support clinical operations, including the CROs, IRBs, DMCs and PVO (collectively "the Outsourcers"), where interests are aligned, allows studies to run smoothly and that Outsourcers should do the "heavy lifting" while the sponsor should provide guidance and oversight. Sentrx offers Pharmacovigilance Synergy on your terms with database, safety event analysis and submission all from a single provider.
For complete Pharmacovigilance Synergy (database, safety event analysis and submission), please contact Sentrx at 973-812-7575 or visit www.sentrx.com.
Sentrx is a pioneer in pharmacovigilance outsourcing service and is a leading provider of technology-enabled solutions and services for global drug safety. Its mission is simple - to be the best pharmacovigilance outsourcing company in the world. Sentrx helps pharmaceutical, biotechnology, medical device, and consumer health companies document the safety profile of their products during clinical development and post-approval, enabling them to minimize risks and maximize benefits. To learn more about Sentrx, please visit the company's website at http://www.Sentrx.com, or call 973-812-7575.