Elevating Clinical Research, Regulatory Writing & Trial Analytics
Industry-aligned consulting and executive education mapped to NEP 2020 credit frameworks, NAAC criteria and modern GCP expectations.
One ecosystem. Six specialist capabilities.
From site startup to data lock, from regulatory writing to executive certification, Clinovitas connects academic capability with CRO and sponsor expectations.
Regulatory Startup
CTA/CDA/MSA support, protocol amendments, EC/IRB submissions and startup milestone tracking.
Clinical Trials / SMO
Feasibility, site selection, recruitment, ICF workflows, SDV and GCP-ready site operations.
Clinical Data Management
eCRF, DVS, edit checks, coding, queries, discrepancy management and database lock workflows.
Biostatistics
Sample size, statistical modelling, PRISMA systematic reviews, meta-analysis and analytics.
Drug Information Centre
Medical inquiries, evidence indexing, product monographs and pharmacovigilance support.
Academic Academy
Executive masterclasses and institutional partnership models for pharmacy and life-science colleges.
Build an audit-ready skill ecosystem inside your institution.
Clinovitas supports colleges with structured masterclasses, attendance logs, graded assessment matrices, syllabus mapping and verified certificates designed around institutional quality requirements.
Industry-ready learning
Clinical research • CDM • PV • Biostatistics
Specialized Services for Clinical Research
Explore our five core service areas and their key activities.
01 Regulatory Writing, Site Startup & CTA Contracting Regulatory documentation · Agreements · Startup coordination +
- Drafting, reviewing, redlining, and negotiating Clinical Trial Agreements (CTAs), Master Service Agreements (MSAs), and Non-Disclosure Agreements (CDAs/NDAs).
- Coordination of Protocol Amendments, EC/IRB resubmissions, and CTRI regulatory documentation.
- Startup milestone tracking, investigator budget negotiations, and site turnaround time (TAT) optimization.
- Tracking operational metrics via SAMS, UCV, and electronic Trial Master Files (eTMF).
02 Site Management Organization (SMO) & Site Operations Site feasibility · Subject recruitment · GCP oversight +
- Site feasibility assessments, site selection dossiers, and investigator meeting coordination.
- Source Data Verification (SDV), Subject Recruitment/Retention strategies, and Informed Consent Form (ICF) workflows.
- Audit-ready Trial Master File (TMF/eTMF) oversight and GCP compliance monitoring.
03 Clinical Data Management (CDM) eCRF design · Medical coding · Database lock +
- End-to-end data lifecycle: eCRF Design, Data Validation Specifications (DVS), and Edit Check programming.
- Medical Coding utilizing MedDRA (Medical Dictionary for Regulatory Activities) and WHO Drug Dictionary (WHO-DD).
- Electronic Data Capture (EDC) navigation, query generation, discrepancy management, and database lock workflows.
04 Biostatistics & Advanced Data Analytics Statistical analysis · Meta-analysis · Analytical software +
- Sample size calculations, statistical modeling, descriptive and inferential statistics.
- Systematic Reviews & Meta-Analyses adhering to PRISMA guidelines (Pair-wise and Network Meta-Analysis - NMA).
- Analytical Software Suites: IBM SPSS, GraphPad Prism, Python, R, and Base SAS.
05 Drug Information Centre (DIC) & Medical Writing Medical writing · Drug information · Pharmacovigilance +
- Product monographs, investigator brochures, and Clinical Study Reports (CSR - ICH E3).
- Medical inquiry management and evidence-based drug literature indexing.
- Pharmacovigilance: Individual Case Safety Report (ICSR) processing, safety narrative preparation, and MedDRA adverse-event triage.
Designed for institutions, professionals and research teams.
Operational Precision
Structured workflows, milestone tracking and documentation designed around trial realities.
Academic Translation
Convert academic curricula into practical competencies that map to CRO, sponsor and SMO environments.
Credential Trust
Digital verification architecture supports transparent employer and institutional credential checks.
Ready to move from theory to clinical practice?
Apply for the 48-Hour Executive Certification.