A critical time for public & private sponsors of clinical research has arrived, as it is important for a contract research organization to maintain optimal operations to effectively support a sponsor’s strategic goals as well as deliver the highest quality data. Hence CRO’s must require deep analysis of performance & alignment across operational functions from regulatory compliance supported by information governance to ensure patient recruitment, budgeting and workflows
To discuss the do’s and don’ts for clinical trial regulation operations, we need to analyze it via the five key areas in clinical research
- Regulatory Compliance
- Information Flow & Governance
- Getting a fast start
- Staff workflows
Faced with numerous timelines and overlaps, clinical research studies can be at risk for schedule slippages. But ensuring a clear project planning at the onset will ensure timely commencement of work.
Informational flow & Governance of latest Clinical Trial Application
Every department holds very critical information about the clinical study and lack of communication among team could jeopardize the entire working system. So creating a communicational plan for across departments along with Sponsors, CRO’s, Vendors will ensure better collaboration across all facets of the project
Getting a Fast Start: A delayed final protocol can cause critical delays to the patient recruitment procedure, hence planned and transparent planning for delays can help a CRO maintain engagement & adapt to changes
Budgeting: With clinical research comes uncertainty which sometimes makes the budgeting process a game of guessing. However, effective change management can help to minimize the risk of any surprises along the way
Staff Workflows: Inefficiently staffing projects can drive delays, quality issues and other delivery problems. Hence developing a core process and aligning key resources allows the CRO to serve more efficiently to the sponsors. For more information click here .