Quality Data...Delivered by Design™

Quality Data...Delivered by Design™

Case Studies

Efficient Adjudication Process using CTMS system

Situation: During previous clinical trials, patient data were copied and mailed to each adjudicator for review. This process works with small numbers but when several adjudicators are reviewing hundreds of thousands of pages from thousands of patients, this process and recording the outcome can be a logistical challenge. A procedure was required to manage the documents and the adjudicator review efficiently and cost-effectively and to document all patients' data were adjudicated.

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Real-Time Monitoring™ using CTMS for IVD Study Sample Collection

Situation: The Sponsor and Research Dynamics needed to know the demographics of the samples tested for an In-Vitro Diagnostic (IVD) study in real time to ensure that samples met the required demographics as well as other characteristics and were being collected and tested efficiently.

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Real-Time Monitoring™ for Early Study Completion

Situation: Sponsor needed 2 more studies to complete their NDA package. The completion of these 2 studies was on the critical path to filing the NDA on time. Each study had 110 subjects and from study start (1st subject recruited) to locked database was planned for a quick 3.5 months including 2.5 months of treatment. Data must be captured and monitored efficiently to ensure meeting the aggressive database lock deadline 1 month after 220 cohort patients complete 220 concurrent last patient last visits (LPLV).

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Rescue Study to Meet NDA Deadlines

Situation: Sponsor had six (6) ongoing studies that were behind schedule and critical to the upcoming NDA filing. If they reported late, the NDA filing date would be missed. The current large CRO was unable to resolve this situation. RDCG was able to provide monitoring to meet database freeze in 4 to 10 weeks depending on the study. Seven hundred (700) subjects data needed to be monitored at all sites. RDCG's activities included completing all CRF monitoring and query resolution at all sites in time to meet database deadlines.

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