CRO Services

Contract Research Organization (CRO) Services

Accelerate Innovation. Ensure Compliance. Optimize Outcomes.

At Stark Pharma, we deliver comprehensive CRO services tailored for pharmaceutical, biotechnology, and medical device companies—supporting the entire product lifecycle from discovery to commercialization. With operations across the USA, Canada, and India, our expert teams blend scientific excellence, regulatory insight, and operational agility to ensure your projects stay on time, on budget, and in compliance with global standards.

Full-Service CRO Capabilities

We offer end-to-end clinical, regulatory, and development services through a flexible, scalable model:

Clinical Development

• Protocol design and feasibility
• Site selection, initiation & trial management (Phases I–IV)
• Patient recruitment & engagement
• eCRF design, data capture, and trial monitoring

Regulatory Affairs

• IND, NDA, ANDA, 510(k), and CE Mark submissions
• Global strategy for US FDA, EMA, CDSCO, TGA, and Health Canada
• Dossier compilation & lifecycle management
• Promotional & labeling compliance

Quality & Compliance

• GxP audits (GMP, GCP, GLP)
• Vendor qualification & inspection readiness
• Risk-based quality systems (RBQM)
• Deviation, CAPA & change control programs

Medical Writing & Documentation

• Protocols, IBs, CSRs, CERs, PSURs
• Regulatory modules (CTD/eCTD: Modules 1–5)
• Safety narratives and literature summaries

Biostatistics & Data Management

• SAP development and statistical review
• Data cleaning and SDTM/ADaM dataset creation
• SAS programming and analysis report generation

Pharmacovigilance & Drug Safety

• Case processing and MedDRA coding
• Signal detection and aggregate safety reports (DSUR, PBRER)
• Safety database setup and management

Medical Device Design, V&V, and Prototyping

We specialize in early-stage to pre-market development for Class I, II, and III medical devices, including combination products and SaMD.

Design & Development

• User Needs, Design Inputs/Outputs, and Risk Management (ISO 14971)
• Design History File (DHF), DMR, and DHR documentation
• Design Controls and traceability matrices

Verification & Validation (V&V)

• Electrical, mechanical, and software verification testing
• Usability testing (per IEC 62366)
• Process validation and shelf-life testing
• Cleaning validation, sterilization validation (EtO/Steam/Radiation)

Prototyping & Pilot Production

• CAD/CAM development and 3D printing
• Functional prototypes for design iteration and testing
• Small-batch manufacturing in ISO 13485-certified cleanrooms

Why Choose Stark Pharma as Your CRO Partner?

• Multi-domain expertise across Pharma, Biotech, and Medical Devices
• Global footprint with local delivery – USA, Canada, and India
• Validation-ready digital ecosystem with StarkERP and QMS integration
• Flexible models: Full-service, FSP, or functional outsourcing
• Audit-ready systems aligned with ISO 13485, 21 CFR Part 11, and EU MDR

📩 Get in touch with Stark Pharma to accelerate your product journey—from concept to commercialization—with quality, compliance, and speed.