End-to-End clinical trial support
MEDICEPTION is a CDSCO-approved CRO, providing End-To-End clinical trial support services to pharma and sponsors. We possess comprehensive, end-to-end clinical trial capabilities spanning study design, regulatory documentation, operations, and reporting
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End-to-End Phase I-IV trials
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Special expertise in Ph IV (PMS Studies)
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Interventional Study
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Observational Study
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Real World Evidence (RWE) trials​
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Current Trial Pipeline
1. Study Design & Documentation
Mediception develops all essential clinical and regulatory documents required for national and international submissions, including:
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Clinical Study Protocols (Phase I–IV, observational, and post-marketing)
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Investigator’s Brochure (IB), Informed Consent Forms (ICF), and Case Report Forms (CRFs)
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Clinical Study Reports (CSR) and Statistical Analysis Plans
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IND/ANDA dossiers, CTDs (Modules II–V), and trial authorization filings with DCGI, FDA, EMA, and FSSAI authorities
2. Clinical Trial Management System Support
Mediception offers end-to-end CTMS support, covering:
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Site selection, inspection, and monitoring
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Data entry verification, missing document checks, and query resolution
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Clinical data management and SAS-based data analysis
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Adverse event tracking and pharmacovigilance (PV) reporting
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Quality assurance (QA) and GCP/GMP training for study personnel
3. Statistical and Analytical Expertise
Data are processed using SAS systems for inferential and descriptive analysis. The in-house biostatistics team supports protocol development, interim analysis, and final reporting with regulatory-compliant datasets
4. Regulatory Affairs Integration
Mediception collaborates with agencies such as DCGI and FSSAI, managing dossier preparation, submission, and product registration across categories like drugs, nutraceuticals, vaccines, and diagnostics. The company also handles translation/transcription of regulatory documents (SmPCs, PILs, DCP filings) into global languages for EMA and FDA submissions
5. Quality Assurance (QA/QC) and Training
The QA division ensures GCP/GMP compliance through:
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SOP and protocol training
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Laboratory audits and site inspections
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QC center establishment for clinical laboratories and CROs
