Why is project management of clinical trials important??
IN order to conduct clinical trials, the project management team is required. The clinical trials are a part of the clinical research process that is meant to analyse the effectiveness and safety of a drug. In the success of every clinical trial, a very crucial role is played by a project manager. This acts as a primary liaison to the sponsor. There are a number of clinical research institutes having a meritorious team for appropriate management of clinical trials.
There has been an increasing number of trials in the India providing myriad opportunities for examining current clinical research practices, so as to harness the advantages of the country for meeting the challenges in the pharmaceuticals industry. So, further we will discuss the role of the project management in a clinical research organization that can be broadened to that of the leadership of a project for handling it as a whole and manage the relationship between the stakeholders as well as the team of the project management, including the investigators, sponsors, etc.
The project management of clinical trials in these clinical research organizations is done with the help of a project management system, which is dedicated for a single clinical project. The individuals of the team oversee every aspect of the clinical trials. This team of project management commits unreservedly to provide in time deliverables with management of budget as well as offer them with a wealth of knowledge to assist their clients throughout the process of the clinical operations.
It is an important aspect that a project leader understands the requirements of the Indian regulatory authorities and the authorities of the other countries as well, where the trial data is to be submitted. He is able to ensure the conduct of the trial accordingly. This ability to improve the site selection with the help of the conduction of the accurate site feasibility results in acceleration of the study conduct and hence is helpful in reducing the costs.
In order to deliver high quality study data, effective coordination among the in house teams is required. The management of clinical trials is usually done with the use of software system that is being used by the pharmaceutical as well as biotechnology industries. This system maintains and manages planning, reporting and performing functions, tracking milestones and deadlines along with personal information of the participant. This software is commonly used at the places, where the clinical research is conducted, including the hospitals, physician practices, etc.
Some of the clinical trials management systems are clouds based and are delivered as a service in software, whereas some other software requires servers. Before the trial appropriate planning as well as careful oversight is required, so as to ensure that the subject safety of the trial is maintained throughout the trial and accurate reports are made at the conclusion of the trial. The monitoring of the trial is one of the key activities that are undertaken as a part of management of a trial. There are several courses based on the monitoring of clinical trials.