With globalization and outsourcing expanding their footprints, improved study startup is essential for building speed into the clinical development process – streamlining a key bottleneck – allowing stakeholders to better adhere to established timelines and budgets.
There is intense pressure to speed clinical trials and restrain costs, but inefficiencies tied to complicated protocols, globalization, and paper-based methods have stalled these efforts.
Continual reliance on standalone spreadsheets, multiple databases, and unsecured email without audit trails is inadequate to manage study startup activities, such as, country selection, pre-study visits, site selection and initiation, regulatory document submissions, contract and budget execution, and enrolling the first patient.
Oversight is here to stay, but in the spirit of collaboration, it is most effective as a partnership in which all parties benefit – by enabling greater transparent and visibility into trial data. The intelligence gathered can improve study startup by helping clinical project managers identify bottlenecks, and take corrective action faster.
Successfully executed trials require open and transparent communications, fostering trust – shifting the focus from monitoring to better collaboration.