Country: India

Raptim Research Pvt. Ltd. is a full-service, independent and internationally accredited Contract Research Organization (CRO) with over 20 years of legacy in clinical research. Headquartered in Navi Mumbai, India, and with operational offices in Gandhinagar (India) and New Jersey (USA), Raptim offers comprehensive clinical research services to global pharmaceutical, biotech, and healthcare companies. We adhere to regulatory guidance along with the approved Protocol and Standard Operating Procedures while conducting trials. The organization is compliant with regulatory standards of USFDA, EMA, DCGI, WHO-GCP, ICH-GCP, and Schedule Y. It has successfully completed over 50+ clinical trials across therapeutic areas and has cleared USFDA inspections at 17 multicentric sites in various therapeutic areas. Core Services and Capabilities Early & Late Phase Trials • Phase I-IV Clinical Trials • BA/BE Studies, PK/PD (SAD/MAD), Food Effect & DDI • Biosimilar & 505(b)(2) Studies, Glucose Clamp • Proof of Concept and Clinical Endpoint Studies • Post-Marketing Surveillance (PMS) & Real-World Evidence (RWE) Therapeutic area includes: • Oncology • Respiratory • Psychiatry • Neurology • Endocrinology/Metabolic Disorders • Dermatology • Cardiology • Rheumatology / Orthopedics • Infectious Disease • Gastroenterology • Vaccines Raptim Research Pvt. Ltd also provides services for: Clinical Data Management & Biostatistics • End-to-end CDM: DMP creation, coding, reconciliation, DB lock, SAS export • SAP development, Randomization, Unblinding, TLF generation • CDISC-compliant datasets and regulatory statistical reports • Integrated summaries for regulatory filings (ISS/ISE) Medical & Regulatory Writing • Protocols, Investigator Brochures, Informed Consent, CSR, CTD modules • Literature-based submissions, Safety narratives, and Public Disclosures • Scientific and publication writing including manuscripts, posters, abstracts Medical Monitoring & Oversight • Medical data review, eligibility assessments, deviation handling • Protocol familiarity, oversight during trial conduct and closure • Trend analysis across safety and efficacy parameters Facilities and Infrastructure • Clinical Facility: 370+ bedded GCP-compliant setup with gender-specific units, ICU, crash carts, and 24×7 medical oversight with dedicated 12 beds for Phase I studies • Bioanalytical Lab: NABL-accredited, GLP-certified, with advanced LC-MS/MS systems • Data Management Center: Centrally operated, validated EDC tools (Oopus & Oomnia), real-time query resolution, and remote monitoring • Global Access: Operations in India and USA; strategic partnerships across LATAM, APAC, MENA, and EU Proprietary Digital Tools • Oopus eSource & Oomnia EDC: Integrated systems that offer real-time data entry, automated sync, reduced SDV burden (~60–70% effort reduction), and faster DB lock • Designed for high-efficiency RWE/PMS studies and have been validated across different studies including Phase IV projects with 25,000+ subjects Human Resources • 650+ Professionals including MBBS, MDs, PhDs, MPharm, Lifesciences and experienced clinical trial specialists • Project Managers, CRAs, CTAs, Statisticians, Medical Writers, QA/QC, Data Managers • Dedicated Regulatory Affairs and Medical Monitoring Teams • Experience in handling both domestic and global regulatory submissions and approvals • A collective experience in Leadership of 25+ years in drug discovery and conducting Clinical Trials • A collective experience of +385 clinical trials across all therapeutic segments. Strategic Advantages • Cleared multiple regulatory inspections including USFDA • Global project management with local execution efficiency • Flexible, scalable infrastructure and resource pool • Continuous investment in technology and compliance