Clinical Research & Clinical Trials
As a dedicated Site Management Organization (SMO), Clinovia partners with pharmaceutical sponsors and CROs to conduct Phase II–IV interventional and observational clinical studies across our partner multispecialty hospitals in Nagpur.
Key Capabilities & Deliverables:
- Site Feasibility & Selection: Rapid investigator identification and demographic patient pool assessment.
- Ethics Committee Coordination: Streamlined Institutional Ethics Committee (IEC/IRB) dossiers and regulatory filings.
- Certified Study Coordinators: Dedicated on-site CRCs managing patient consent, visits, and investigational product (IP) logs.
- Audit & Inspection Readiness: Continuous monitoring compliant with ICH-GCP E6(R2) and CDSCO guidelines.
Professional Courses & Training
Clinovia is recognized as Central India's leading career accelerator for life science graduates (B.Pharm, M.Pharm, Pharm.D, MBBS, BDS, BAMS, BSc/MSc Biotech). We deliver four specialized Advance Diplomas featuring hands-on hospital exposure.
Flagship Diploma Tracks:
- Advance Diploma in Clinical Research & Clinical Trials: Site operations, ethics, informed consent, trial monitoring.
- Advance Diploma in Pharmacovigilance & Drug Safety: ICSR, MedDRA coding, safety narrative authoring, ARGUS simulation.
- Advance Diploma in Clinical Data Management (CDM): Rave/Oracle EDC design, eCRF, discrepancy workflow, database lock.
- Advance Diploma in Medical Coding & Billing: ICD-10-CM, CPT, HCPCS, CPC certification preparation, chart auditing.
Clinical Data Management (CDM)
Data integrity is the bedrock of regulatory approval. Clinovia provides comprehensive clinical data management services compliant with GCDMP (Good Clinical Data Management Practices) and 21 CFR Part 11 requirements.
CDM Core Services:
- Data Management Plan (DMP): Protocol-specific data workflow, timeline, and quality tolerance limits.
- eCRF & EDC Architecture: Design and validation of electronic Case Report Forms, edit check programming.
- Discrepancy Management: Manual and automated query resolution, source data verification (SDV) reconciliation.
- Database Lock & Transfer: Blinded data review, medical coding freeze, database freeze, and CDISC SDTM handoff.
Pharmacovigilance & Drug Safety
Patient safety monitoring requires round-the-clock vigilance and strict regulatory reporting timelines. Clinovia delivers comprehensive end-to-end pharmacovigilance solutions for clinical trials and post-marketing surveillance.
PV Capabilities:
- ICSR Case Processing: Intake, triage, medical assessment, and narrative writing for adverse events.
- Standardized Medical Coding: MedDRA coding for adverse events and WHO Drug Dictionary coding for concomitant medications.
- Aggregate Safety Reporting: Periodic Safety Update Reports (PSUR/PBRER), DSURs, and safety signal evaluations.
- Literature Surveillance: Weekly biomedical literature monitoring for published safety signals.
Medical Coding & Billing
Accurate clinical classification ensures revenue integrity and compliant health claims. Clinovia bridges healthcare documentation with global medical coding standards for international US healthcare payers and hospital systems.
Coding Solutions:
- ICD-10-CM & PCS Coding: Diagnosis and procedural code assignment with 98%+ accuracy standards.
- CPT & HCPCS Classification: Outpatient, surgical, and durable medical equipment coding compliance.
- Clinical Documentation Improvement (CDI): Chart abstraction, physician query management, and DRG optimization.
- Certified Talent Sourcing: Direct pipeline for AAPC/AHIMA certified professionals (CPC/CCS).
Medical Writing & Scientific Communication
Translating complex clinical trial data into clear, compliant, and peer-reviewed scientific documents. Our medical writing team supports regulatory submissions and academic publishing for clinical investigators and pharma sponsors.
Document Types:
- Regulatory Documents: Clinical Study Protocols, Investigator Brochures (IB), and Clinical Study Reports (ICH E3 CSRs).
- Informed Consent Forms (ICFs): Subject Information Sheets in English, Hindi, Marathi, and regional languages.
- Peer-Reviewed Manuscripts: Original research articles, systematic reviews, and meta-analyses targeting indexed journals (PubMed, Scopus).
- Conference Presentations: Scientific posters, abstracts, and clinical slide deck preparations.
Need a Custom Clinical Trial or Training Proposal?
Our project coordinators are ready to evaluate feasibility, design site infrastructure, or tailor a corporate training program.
Request Consultation