
Helping Sponsors to Conduct Global Clinical Trials with Uncompromised Quality and Compliance
Techsol has been helping sponsors to conduct and complete multi-centric global clinical trials across various therapeutic areas like Infectious Diseases, Oncology, Cardiology, Gastroenterology, Nephrology, Diabetes, Obstetrics & Gynecology, Urology, Dermatology, Ophthalmology, Neurology, and Parental nutrition. With our domain expertise, we have a well-established clinical operations team for managing the conduct of pre-clinical studies to post-marketing surveillance.
We offer full-range services starting from protocol design, Paper CRF/EDC data management, statistical analysis, study report writing, preparation, tracking and maintenance of study documentation (Study Protocol, Investigator's Brochure, Site Documentation, Principal Investigator Documentation, IRB/EC and other Regulatory documents, Site contracts, Study Case Report Forms, Informed consent forms, Trial supplies and Drug Accountability log, Operational reports, etc.)
What We Can Do
- Patient Pool Discovery
- Site and Investigator Selection
- Site Qualification
- Site CDA /NDA Agreements
Our Capabilities
- Experienced clinical teams across the globe
- Investigator & Site Database
- Regional access to patient pool for different therapeutic areas
- Access to experienced Clinical Sites which have undergone Regulatory Inspections.
- KOL Database across therapeutic database with experience in clinical development
- Close-knit collaboration with leading health universities, educational and research institutions
- Validated feasibility assessment questionnaires across therapeutic areas

Activities We Perform
Site Readiness Planning
- Execute and oversee study specific investigator agreements.
- Patient recruitment & retention plans
- Site Resource Management and Communication Planning
Protocol Development
- Manage and track multiple clinical programs and associated clinical studies
- Track Regulatory submissions and approvals
- Track Sites and Investigator Qualifications for Trial Participation Eligibility
Budget Planning & Allocation
- Plan and forecast trial budget
- Execute budget allocation to study teams
Vendor Selection
- Define new vendor contracts
- Select vendors (Technology Partners (EDC, eTMF, CTMS, RTSM, RBM, Clinical Safety, etc.), Central Labs, Supply Chain, Data Management, Logistics)
- Vendor Qualification based on past performance

How We Can Help
- Facilitating investigator meeting
- GCP training to site staff
- IEC/IRB submission and approvals
- CTRI registration
- Protocol training
- TMF Setup and maintenance
- Safety management training
- Preparation and implementation of study specific monitoring plans
- Conduct study initiation visits (SIV)
- Site Activation
How We Can Help
- Subject Recruitment and Retention
- Risk based monitoring / Centralized monitoring
- Trial Master File (TMF) Management
- In-house Investigator Site File (ISF)
- Randomization, Blinding/Unblinding
- Drug Accountability / IP Management
- Site coordination and management
- Central Labs Management
- Clinical trial supplies and management
- Manage adverse event reporting and documentation
- Source data verification (SDV) and quality checks at sites
- Subject Compensation
- Investigator Payments
- Protocol deviations/violations
- Regulatory, IRB / IEC Communications
- Oversee Site performance and compliance
- Site readiness for Audits & Regulatory Inspections
Activities We Perform
Sites Closeout Planning
- Proactive Planning for Site Closeout Visit
- Define, Update and Track Site closeout Visit Activities
- Track Drug Accountability
- Complete pending payments
Study Documents Archival
- Site specific essential documents reconciliation
- Trial Master File Documents Archival
- Update and closure of Contracts and Agreements
Site-Closeout Execution
- Outstanding Queries Resolution
- Study Database Lock/ Freeze
- Preparation of CSR
Reporting of Clinical Study Outcomes
- Generation of Trial Summary Reports
- Reporting of Study Budget Expenditure
- Clinical Project & Program Outcomes Review
Regulatory, IRB / IEC Communication
- Notification to Local and Global Regulatory bodies
Clinical Development Technology Platforms
