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
New Insights
Emerging Trends in Regulatory Affairs by Adapting to Latest Technological Advancements
Globally, Life Sciences and Pharmaceutical industry continues to adopt advanced technology and novel therapies to improve quality of medicines, medical devices and biologics. But legacy guidelines do not offer enough regulation over these evolving ways of triage and treatment. To ensure the high quality medicines and diagnostics are available for patients, regulatory agencies identify and [...]
ICH’s eCTD Version 4.0 – Objectives, Major Updates, Resulting Advantages and Possible Challenges
ICH’s eCTD Version 4.0 The Electronic Common Technical Document (eCTD) has become the global standard for electronic submissions in the Life Sciences industry. An eCTD submission has five modules: Region-specific information Summary documents Quality-related information Nonclinical study reports, and Clinical study reports. Most global regulatory agencies such as US FDA (USA), EMA (EU), Health Canada [...]
Global Regulatory Changes in Biopharma
Evolution in Global Pharmaceutical Regulatory Landscape & Notable Changes for Sponsors Pharmaceutical companies must comply with regulations set forth by respective regulatory agencies right from the pre-clinical to post-marketing phases of clinical development. Each regional agency has a wide array of stringent guidelines for various processes to ensure patient safety and product quality. With changing [...]