Even under the best circumstances, the clinical trial lifecycle is an enormous undertaking. From study design to publication and application, clinical trials come with many moving parts— and the process grows more complex each year. Whether it’s a large multinational pharmaceutical company or a smaller trial sponsor with few ongoing studies, trial sponsors conduct simultaneous studies in countries with increasingly involved legal, regulatory, and compliance requirements.
In the rush of everyday study workflows, disclosure considerations can seem like a tedious obstacle—and often falls to the bottom of overcrowded to-do lists. However, a rising number of countries now require the public disclosure of clinical trial data and documents before product approvals. Operationalizing regulatory checkpoints throughout clinical lifecycles is the shortest path to market in a world of mounting regulatory laws and non compliance consequences.
Regulatory intelligence goes beyond ensuring compliance. It optimizes the clinical trial lifecycle so sponsors don’t have to scramble to complete last-minute disclosures or face non compliance penalties. By monitoring and understanding these integral disclosure obligations, sponsors can position clinical trials for seamless completion from the start:
- Minimize regulatory risks—from fines to jail time
- Spend less time training new employees on regulatory standards
- Devote more attention to strategy instead of detailed compliance tasks
- Win the respect of investors, pharma watchdogs, patient advocacy groups, and the public
The key to taking control of disclosure intelligence is situational awareness. Read on to discover how comprehensive and proactive compliance management can help your organization operationalize disclosure intelligence—and establish your company as an industry leader.