Are you looking for real-time answers to these questions:
- How is my CRO performing against the quality agreement?
- Is the oversight plan working? If not, what changes need to be made?
- What issues need to be escalated?
You are not alone. In fact, in a recent survey only 34% of ClinOps leaders indicated that they successfully achieved their planned CRO goals.
What is CRO Oversight? When outsourcing a clinical study, the sponsor transfers over several core responsibilities and obligations to a contract research organization (CRO). Adherence to these responsibilities and obligations is critical to the success of the clinical study and is heavily regulated by national agencies such as the U.S. FDA, Europe’s EMA and MHRA, Health Canada, etc.
Several 483 forms issued by the FDA after sponsor inspections will include this brief but damaging label: “Failure to ensure proper monitoring of the study”. The expectation that sponsors oversee their CROs continues to put pressure on Clinical Operations leaders, as proven by many recent regulatory inspections and statistics issued by these agencies. At minimum, it is essential to have the ability to tell a regulatory inspector that the CRO did what they were hired to do.
Why CRO Oversight?
Although sponsors are increasingly using CROs and are anticipating changes in the processes governing CRO management due to pending ICH E6 updates, the majority of the operational leaders in the biopharma industry are not confident their CROs will achieve milestones on-time and do not believe their relationship is productive.
Comprehend’s Automated Solution
1. Template Quality Agreement
“What to Measure”
CRO oversight is driven by goals and metrics that ensure shared organizational direction. If the CRO lacks direction or has no shared goals and metrics, then they will just do what they believe to be best. Misalignment arises when there are either different opinions or misinterpretations on the goals and metrics. Both can set the team in a direction that undermines overall performance. With fundamental alignment of the players, the right goals and metrics reinforced throughout the partnership will enable the sponsor to achieve the speed they need and quality results.
2. Template CRO Oversight Plan
“How We Will Measure”
The CRO Oversight Plan is a guideline for the ClinOps Vendor Managers to ensure the vendor’s adherence to the Scope of Work (SOW), study-specific plans, processes, procedures, and GCP. The Vendor Managers are assigned as the sponsor’s primary contacts, and they are responsible for monitoring the vendor’s performance including timelines, milestones, quality, deliverables, and budget adherence. Although sponsors may delegate clinical trial activities and functions to vendors, the sponsor is ultimately accountable and will perform oversight of the clinical activities and functions.
|1. KPI Monitoring||Daily||Centralized automation of the quality agreement, pre-defined thresholds for escalation|
|2. Issue Management||Weekly||Raise issues in system, resolution turnaround time|
|3. Escalation||As needed||Step-by-step actions for critical issues, two-sided governance system, path from “functional team” to “project leader” to management|
3. Automation with Clinical Intelligence
In order to manage increasing data complexity with multiple CROs and adhere to the ICH E6 (R2) addendum, ClinOps leaders are agreeing that automating the quality agreements and oversight plans for transparency of the right goals, metrics, issues, and escalations will enable CROs to focus on what matters and act faster.
Continuous certainty that the CRO is adhering to quality plan
Clinical Intelligence provides transparency on data and operational systems, collaboration, and real-time monitoring to ensure a successful sponsor/CRO relationship.
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