Case In Point
Successful Data Management Rescue for Multiple Ophthalmology Studies
About Client
A biotechnology company was conducting four Phase II/III clinical trials in the Ophthalmology therapeutic area. Initially, the company outsourced Clinical Data Management (CDM) to a large contract research organization (CRO). However, after experiencing a series of delays, escalating costs, and multiple compliance issues, the sponsor decided to transition the project to a new CRO with a more specialized and responsive approach.
Challenge
- Data Integrity Issues: Inconsistent data entry and incomplete records raised concerns about the reliability of trial data.
- Regulatory Non-Compliance: Audit findings revealed deficiencies in documentation and adherence to Good Clinical Practice (GCP) guidelines.
- Delays in Database Go-Live: The original CRO failed to meet key milestones, causing significant delays in the database’s go-live.
- Poor Communication: The sponsor lacked visibility into data status, leading to delays in decision-making.
- Cost Overruns: The original CRO presented increased scope and change orders, exacerbating costs.
Solution
The sponsor engaged Everest, a specialized CRO with a proven track record in clinical data management rescues. The following steps were implemented:
- Rapid Knowledge Transfer: Everest conducted an intensive knowledge transfer process using a rescue transition checklist. This included a forensic data audit to identify gaps and inconsistencies in the existing data.
- EDC Migration: The study data was separated from other non-sponsor studies hosted on the same Medidata URL, ensuring a clean transition to a new environment.
- Data Cleaning and Validation: A dedicated data management team revalidated the clinical database, addressing inconsistencies and implementing stringent quality control measures.
- Process Optimization: Everest implemented an agile project management framework, improving communication and providing the sponsor with real-time data transparency.
- Accelerated Database Lock: By leveraging automated tools and advanced analytics, Everest streamlined the database lock process, reducing delays and ensuring on-time delivery.
Results
- Timely Data Entry: Improved site data entry through system enhancements and clearer data capture requirements.
- Restored Data Quality: Data management discrepancies were resolved within six weeks.
- Regulatory Compliance Achieved: A follow-up audit showed no critical findings, ensuring full compliance.
- Timely Database Lock: Two of the four projects, which were initially delayed, were successfully locked within their original timelines.
- Enhanced Sponsor-CRO Collaboration: Real-time dashboards and proactive communication strengthened the sponsor’s confidence in decision-making and the CRO’s capabilities.
