Clinical trials are a highly complex undertaking. Effort in planning and set-up pays off in later management, data collection, and regulatory reporting. With so many moving parts, however, clinical trial teams can be hard-pressed to create a single system or approach that utilizes best practices for every aspect of the trial.
In particular, clinical trial teams face three major challenges in trial set-up and management:
- Document set-up and management can be overwhelming; the wrong document system can cause errors to proliferate.
- Maintaining regulatory compliance, tracking changes in regulatory demands, and discerning among requirements, guidance, and best practices places additional burdens on clinical trial teams — with potentially steep consequences for mistakes.
- Clinical trial financial forecasting and budgeting can delay a clinical trial, raise ethics questions, or create additional regulatory issues.
However, each of these problems can be overcome with an automated, integrated Clinical Trial Management solution like Anju’s CTMS Master. In this white paper, we zoom in on these top three challenges and effective ways to address them.
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