Rapid and efficient eCRF design and build in leading EDC platforms.
Enabling proactive identification of data issues and site risks in real time.
Our team ensures terminology alignment, SAE classification, and compliance with regulatory and sponsor-specific standards.
Rapid and efficient eCRF design and build in leading EDC platforms.
Enabling proactive identification of data issues and site risks in real time.
Our team ensures terminology alignment, SAE classification, and compliance with regulatory and sponsor-specific standards.
Of combined experience in Data Management for Clinical Research.
Extensive experience across Neurology, Cardiology, Oncology, Ophthalmology, Gynecology, Nephrology, Dermatology, Internal Medicine, and Aesthetic Medicine.
Hands-on experience delivering reliable expertise across all levels of research complexity.
Our Clinical Data Management Services combine deep expertise and GCP‑compliant systems to support seamless clinical trial data management from start to finish. We specialize in data collection, eCRF design, validation, database build, and query resolution, ensuring high‑quality, regulatory‑ready data. Serving biotech, pharma, and CRO clients, our turnkey solutions enhance efficiency and data integrity across all trial phases. Leveraging real‑time reporting and audit‑ready documentation, we help sponsors accelerate timelines and meet ICH/FDA requirements.
Our team specializes in managing high-complexity studies involving adaptive designs, multiple cohorts, high data volume, and intensive safety oversight. We ensure precise data handling, robust quality control, and adherence to accelerated timelines without compromising compliance or integrity.
Our proprietary CTMS platform streamlines risk-based monitoring, central data review, and quality oversight. It enables real-time metric tracking, issue escalation, and proactive decision-making, ensuring consistent data quality and operational efficiency across all study phases.
We manage electronic Patient-Reported Outcomes (ePRO) with a focus on data integrity, timeliness, and regulatory compliance. Our services include ePRO setup review, query handling, reconciliation, and integration into clinical databases. This ensures high-quality patient-reported data ready for analysis and submission.
With 9 in-house Data Managers, the GCPS team will make sure you get the support you need for your study.
Successfully created and curated over 30,000 datapoints, demonstrating robust capacity in data entry, validation, and quality control across complex studies.
We deliver fully functional EDC (eCRF) systems within an average of just 50 working hours.
