Clinical research management requires a very keen sense of organization in order for it to be efficient. Clinical trials, big or small, by nature, are complex undertakings. Hence, in order to implement first-rate trials, the management side of it needs to be given the importance it deserves.
Experts have identified the stages in project management: initiation, planning, execution & control and analysis & reporting. Too often in clinical trials, the initial stage do not include clinical research managers because of budgetary constraints[1]. However, the involvement of a clinical research manager right from the design stage can eventually translate into savings. Because of the huge amount of financial resources required to successfully implement clinical research trials, such savings should be considerable.
The failure to involve a clinical research manager right from the initial stages may cause delays, most especially in applying for funding - a critical phase of any undertaking. The clinical research manager’s inputs during the design phase can plug loopholes that may become evident in the implementation stage.
Clinical research managers should be actively involved in every aspect of the trial and put in place systems and procedures for effective monitoring. Considering the number of people involved in clinical trials; Investigators, statisticians, administrative staff, not to mention patients – an effective management system needs to be put in place and implemented properly.
It seems like a Herculean task but with proper training and appropriate experience, a clinical research manager can bring any trial site to succeed.
[1] Source: Managing Clinical Trials http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2917433/