CLINOVITAS LIFESCIENCES / OUR SERVICES

Core Services &
SMO Site Management.

Integrated clinical research, site operations, regulatory writing, data management, biostatistics and medical information services.

OUR EXPERTISE

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.