Project management in clinical trials is an essential component for study progress. Clinical trials are usually complex projects that require sufficient planning and leadership. Successful project managers not only have an extensive and concrete plan for their protocols but they also ensure that each step is thoroughly monitored and accurately timed. Assigning this planning to the appropriate project manager is the key to a favourable outcome.
The role of the project manager relies on his ability to effectively supervise the project and make sure that all processes are regulatory compliant, every step is executed within budget and the most applicable to each project actions are adopted.
Effective communication among the project manager, the team members and every stakeholder involved is one of the most important steps when designing and executing a clinical trial. Projects may be negatively affected by false assumptions made due to the lack of information transmission. A clear understanding of everyone's responsibilities and involvement in the clinical trial is pivotal and the project manager must ensure that transparency and understanding of the objectives are communicated to everyone.
After ensuring that the communication guidelines are clearly outlined, the project manager should act proactively and plan for contingencies that can be anticipated in large-scale projects such as a clinical trial. This foresight allows the project managers to predict potential obstacles along the way and increase the possibilities for success.
Throughout the course of a clinical trial, data analysis should be performed constantly and in detail. All collected data, when analysed accurately, will allow the project manager to foresee any unexpected problems and make all the necessary changes in order to continue running the project smoothly and within the suggested timelines. A detailed plan of how the trial will operate on a daily basis is also highly recommended.
The trial manager should be involved in the trial design at an early stage if possible and be able to work proactively, plan effectively and assess every potential risk until the end of the study. It is essential that the project management strategy will encompass all relevant information for developing and monitoring all stages of the trial lifecycle.
Effectively managing and carefully selecting the right partner, which will be a
ble to provide the right project management planning for your trial, will ensure the adoption of the right strategy in order to bring you a step closer to study success.
TCTC Group ensure that all their project managers excel in these standards.
Farrell, Barbara et al. Managing Clinical Trials. http://www.trialsjournal.com/content/11/1/78
Farrell B, Kenyon S A Guide to Efficient Trial Management. http://www.tmn.ac.uk/guide.htm