Clinical Study
Clinical Trial Services for Medical Devices – CDSCO, FDA & CE Compliant
Protocol Development
We specialize in the design and drafting of scientifically sound, ethically robust clinical protocols aligned with global regulatory expectations (CDSCO, ISO 14155, ICH-GCP). Our team ensures the protocol accurately reflects study objectives, methodology, statistical endpoints, and patient safety considerations, forming a reliable foundation for successful trial execution.
Biostatistics Analysis
Our biostatistics experts support both study design and post-trial data interpretation. From calculating sample sizes to developing comprehensive statistical analysis plans, we ensure data robustness. Post-study, we perform statistical evaluations that substantiate the clinical safety and performance of your device, supporting regulatory submissions and scientific publications.
Site Identification
We identify high-quality clinical trial sites based on therapeutic expertise, investigator credentials, recruitment capabilities, and infrastructure. Our established network of hospitals and diagnostic centers across India enables faster study start-up and efficient patient enrollment.
Institutional Ethics Committee (IEC) Approval
We manage end-to-end IEC submission processes, including preparation of protocol packages, informed consent documents, and supporting materials. Our expertise in addressing IEC queries and ensuring ethical compliance accelerates site initiation timelines.
CTRI Registration
We facilitate the mandatory registration of clinical studies with the Clinical Trials Registry–India (CTRI), ensuring transparency and compliance with Indian regulatory mandates. Our team handles documentation, submission, and timely follow-up to secure approvals efficiently.
CRA and Investigator Training
We provide customized Good Clinical Practice (GCP) training and protocol-specific instruction for Clinical Research Associates and Investigators. This ensures that all site personnel are well-versed in regulatory expectations, data integrity, adverse event reporting, and subject protection.
Subject Enrollment
Our team designs targeted recruitment strategies, enabling efficient identification and enrollment of eligible study participants. We support screening processes, informed consent management, and subject retention to ensure data validity and minimize dropout rates.
Data Collection
We implement compliant, standardized data capture processes using paper-based or electronic CRFs (eCRFs). Our team ensures high-quality data collection through regular site monitoring, source data verification (SDV), and real-time data resolution workflows.
Data Analysis
We deliver end-to-end statistical data analysis aligned with the pre-approved statistical analysis plan (SAP). From primary endpoint evaluation to subgroup analysis, our services ensure that your study outcomes are scientifically defensible and suitable for regulatory review.
Clinical Evaluation Report (CER)
We prepare detailed Clinical Evaluation Reports in accordance with MEDDEV 2.7.1 Rev. 4 and EU MDR requirements. Our CERs integrate data from clinical investigations, literature reviews, and post-market surveillance to support CE marking and global regulatory submissions.
Post-Market Study (PMS)
We support the design and execution of post-market clinical follow-up (PMCF) and surveillance studies. These activities help generate real-world evidence on long-term safety, effectiveness, and device usability—critical for regulatory compliance and ongoing risk management.