Sentrx Offers Efficient Solutions for Client's IRB or Data Monitoring
Sentrx discusses the importance of outsourcing data monitoring to a sole entity.
Little Falls (I-Newswire) November 15, 2012 - 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.
Sentrx is a leading provider of technology-enabled solutions and services for global drug safety. It More..s mission is to help 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. Through its multilingual Safety Response Center, Sentrx delivers a unique combination of highly skilled medical experts, exclusive technology, and best practices in drug safety monitoring. To learn more about Sentrx, please visit the company's website at http://www.Sentrx.com, or call 973-812-7575.Less..
150 Clove Road
Phone : 973-812-7575
Tags:technology device risk management Pharmaceuticals biotechnology drug safety Medical Affairs Drug Safety Provider
Published in:Health & Fitness
Published On:November 15, 2012
Print Release:Print Release
If you have questions regarding information in this press release contact the company listed above. I-Newswire.com is a press release service and not the author of this press release.The information that is on or available through this site is for informational purposes only and speaks only as of the particular date or dates of that information. As some companies and PR Agencies submit their press releases once per week,month or quarter, make sure to check the official company website for accurate release dates as our site displays the I-Newswire.com press release distribution date only.We do not guarantee the accuracy or completeness of information on or available through this site, and we are not responsible for or omissions in that information or for actions taken in reliance on that information.
Find The Online Resource To Get Information On Acne Treatment
India Pharmacy Retail Outlook - Growing Pharmaceutical Sector with Consumer Awareness Is Propelling Indian Pharmacy Retail Market
Dentalcarenetwork.com Offers the Most Effective and Reliable Dental Implants Gold Coast
Dakota Dental Offers Patients Extended Sedation Dentistry Options
Recoveryas.com Presents at "Innovations in Recovery"