Tag Archives: Investigators

Clinical Investigators Meetings and Rational to Use an Investigator Meeting Planner

Pharmaceutical companies spend approximately 10 years and 1 billion dollar per drug to before it is launch to the market. A phase III clinical trial must be conducted for every new drug application to FDA for approval before a pharmaceutical company is able to market this drug to the public. The purpose of the clinical trial is to ensure the safety and efficacy of the new test product . The data collected is analyzed and a clinical study report is submitted to FDA who will the approve or reject the NDA submission.

Every clinical trials will have a Investigators Meeting prior to the first patient enrolled.

A clinical investigators meeting main purpose is to ensure the study is conducted according to regulatory and ethical guidelines and the sites implement the study according to the protocol. As most phase III trials are global involving more than a hundred of principal investigators and thousands of patients, ensuring consistency and compliance to the protocol procedures are critical to the success and validity of the clinical trial data. Safety guidelines needs to be adhere to in the protocol to ensure the safety of the patients in the trial.

Clinical Trials Investigators Meeting is one strategy at the start up phase of the study to ensure that everyone on the study team understands the protocol and related procedures. The protocol presentation is perhaps the most critical element because any section of the study that is not clear or believe to impact on patient enrollment will be discussed with follow up action plans. As most clinical investigators would be familiar with the study during this junction from the feasibility and pre study visit, the protocol, section focus more on discussing critical issues impacting the study conduct and a forum for all Clinical Investigators to get together and discuss all points of view and expertise.

In addition to protocol training Clinical Investigators will be trained about the administration and handling of the new test product. Strict adherence on drug dispensing, prescribing, compliance and drug accountability procedure are discussed in detail the clinical investigator meeting. Detail discussion about potential side effects and permissible concomitant treatment are discussed in the protocol. Procedures for defining a serious adverse events and intervention as outline in the clinical trial investigator meeting.. Clearly define roles and responsibility of the clinical investigators are also outline during this meeting.

Clinical investigators meeting is also an opportunity for all sites around the world to meet and build relationships. The physicians involved in the clinical trial need to work together as a team. . This meeting is the kickoff that motivates all parties and unites them in their effort to validate the new drug product for human consumption that is believed to be more effective and safer for mankind. . It is an expensive time consuming and essential start up activity in the effort to earn FDA approval of the new drug application. As these meetings often are complex to organize and handle, most pharmaceutical and biotechnology companies sponsoring the clinical trials will engage an Investigators Meeting Planner to ensure the meeting is a success.

Full regulatory compliance consultancy services at http://www.complianceconsultant.org

Source by Pao Mei Lee