| Pharmaceutical companies spend approximately 10 | | | | pre study visit, the protocol, section focus more |
| years and 1 billion dollar per drug to before it is | | | | on discussing critical issues impacting the study |
| launch to the market. A phase III clinical trial must | | | | conduct and a forum for all Clinical Investigators |
| be conducted for every new drug application to | | | | to get together and discuss all points of view and |
| FDA for approval before a pharmaceutical | | | | expertise. |
| company is able to market this drug to the public. | | | | In addition to protocol training Clinical Investigators |
| The purpose of the clinical trial is to ensure the | | | | will be trained about the administration and |
| safety and efficacy of the new test product . | | | | handling of the new test product. Strict adherence |
| The data collected is analyzed and a clinical study | | | | on drug dispensing, prescribing, compliance and |
| report is submitted to FDA who will the approve | | | | drug accountability procedure are discussed in |
| or reject the NDA submission. | | | | detail the clinical investigator meeting. Detail |
| Every clinical trials will have a Investigators | | | | discussion about potential side effects and |
| Meeting prior to the first patient enrolled. | | | | permissible concomitant treatment are discussed |
| A clinical investigators meeting main purpose is to | | | | in the protocol. Procedures for defining a serious |
| ensure the study is conducted according to | | | | adverse events and intervention as outline in the |
| regulatory and ethical guidelines and the sites | | | | clinical trial investigator meeting.. Clearly define |
| implement the study according to the protocol. As | | | | roles and responsibility of the clinical investigators |
| most phase III trials are global involving more than | | | | are also outline during this meeting. |
| a hundred of principal investigators and thousands | | | | Clinical investigators meeting is also an opportunity |
| of patients, ensuring consistency and compliance | | | | for all sites around the world to meet and build |
| to the protocol procedures are critical to the | | | | relationships. The physicians involved in the clinical |
| success and validity of the clinical trial data. Safety | | | | trial need to work together as a team. . This |
| guidelines needs to be adhere to in the protocol to | | | | meeting is the kickoff that motivates all parties |
| ensure the safety of the patients in the trial. | | | | and unites them in their effort to validate the |
| Clinical Trials Investigators Meeting is one strategy | | | | new drug product for human consumption that is |
| at the start up phase of the study to ensure that | | | | believed to be more effective and safer for |
| everyone on the study team understands the | | | | mankind. . It is an expensive time consuming and |
| protocol and related procedures. The protocol | | | | essential start up activity in the effort to earn |
| presentation is perhaps the most critical element | | | | FDA approval of the new drug application. As |
| because any section of the study that is not clear | | | | these meetings often are complex to organize |
| or believe to impact on patient enrollment will be | | | | and handle, most pharmaceutical and |
| discussed with follow up action plans. As most | | | | biotechnology companies sponsoring the clinical |
| clinical investigators would be familiar with the | | | | trials will engage an Investigators Meeting Planner |
| study during this junction from the feasibility and | | | | to ensure the meeting is a success. |