Single Central Data Management Cell: The ‘Quality’ Advantage
What can sponsors gain from a single Central Data Management team working on their behalf?
1. Functional Core competency in Data Management: Outsourcing all elements of a trial to a single CRO to oversee everything may seem like the simplest option to Sponsors.
However, E6 R 2 amendments now include stricter responsibilities for Sponsor Oversight of clinical trial processes AllCROs may not have strong Data Management and Project Coordination as core competencies.
Therefore, a foolproof way to show evidence of strong sponsor oversight, is to employ a single core Data Management team with strong Project Coordination capabilities as your internal DM cell for all your studies.
The core DM team working on behalf of the sponsor monitors, controls and gives regular feedback on the performance of sites and CROs across studies. This gives more control to the sponsor than taking a generalized outsourcing approach, since you can offer objective evidence of hands on Project Management through the action and feedback of your core DM team.
2. Inbuilt Quality Assurance and Project Management: Study Monitors and Site Staff will be monitored by this inhouse team based on agreed metrics so that decisions can be made by you in real time to keep study progress on track at all times.
Standardized performance metrics and timelines applicable across studies ensure consistent performance from all stakeholders
3. Harmonization from consistent expectations: One single control center means standardization of processes across studies.
Allowing site staff to respond to a consistently defined set of sponsor expectations versus differing requirements from various CROs, increases motivation and performance at the site.
Standardization also removes ‘teething problems’ and facilitates a ‘First time right’ approach through rigorous attention to planning, risk assessment and risk control. This reduces chances of rework, dissatisfied stakeholders, firefighting exercises and saves on expenses associated with all these inefficiencies.