Scientific & Operational Expertise to Conduct Regional Clinical Trials With Quality and Compliance
In today’s complex clinical research ecosystem, pharma companies need a trusted partner to translate years of collaborative research into life-saving products. The timely completion of clinical studies requires a powerful combination of therapeutic knowledge, clinical study experience and modern technology to sucessfully generate scientific evidence that ultimately wins a regulatory approval.
With our 20+ years of combined team experience, sponsors have entrusted us as a reliable CRO partner because of our unwavering focus on patient safety, regulatory compliance and data quality. With our domain expertise, we have a well-established clinical operations team for managing the conduct of pre-clinical studies to post-marketing surveillance.
Techsol's Clinical PIVOT Framework
Our team has a track record of successfully engaging with over 40+ sponsors using our proprietary Clinical PIVOT Framework that is powered by having connected teams, processes, and technology. It has six important core components that are fully leveraged to accelerate clinical development and deliver maximum value for sponsors.
Services We Offer
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.)
- Study Essential Documents
- IRB and CA Submissions
- Investigator Selection
- Site Feasibility
- Site Qualification
- Sites & Vendor Contracts
- Site Preparation Activities
- Study Data Mgmt. Planning
- EDC, CTMS, eTMF, RTSM Setup
- Trial Execution Planning
- Facilitating investigator meeting
- Site Personnel Study Training
- CTRI Registration
- Study Monitoring Planning
- Trial Supplies Management
- Risk-based Monitoring & SDV
- Data Cleaning & Query Resolution
- AE / SAE Management
- Quality & Regulatory Inspections
- Subject Tracking & Site Payments
- Protocol deviations & violations
- Drug Accountability
- Vendor Payments
- Outstanding Query Resolution
- Site Close-out Activities
- Study Documents Archival
- IRB / IEC Notification
- Study Database Lock & Freeze
Core Value Delivery Principles
As a CRO, we aspire to deliver competetive end-to-end functional services with these cardinal principles:
- As a Regional CRO, we have completed over 50+ clinical studies across different therapeutic areas
- Our vast Investigator & Sites network provides access to a diverse patient pool
- Our Quality Certifications account for the stringent processes that we follow for delivering results
At Techsol, we are commited in delivering high-quality services in an ethical manner with 100% regulatory compliance.
> Quality Management System: We have a stringent QMS framework with well-defined Standard Operating Procedures (SOPs) and Quality Assurance protocols to ensure consistency and error-free process execution. Our QMS has been audited and appreciated for its effectiveness by several global clients.
> Training & Development: All our team members are periodically trained and assessed on our QMS processes, various regulations such as ICH-GCP, FDA, EMA, etc. and industry best practices.
> Transparent Project Management: Our rigorous quality control measures ensure that studies are conducted in compliance with applicable regulations and guidelines, and our efficient study planning and project management processes help us deliver studies on time and within budget. We also prioritize effective communication and collaboration with our clients, keeping them informed throughout the study process and working closely with them to achieve their clinical trial objectives.
We use the best of technology platforms that helps us to deliver our clinical trial services through continous real-time collaboration with sponsors. Following are some of the systems we use:
Electronic Data Capture (EDC) System: We use next-generation EDC platforms such as Clinical One, Clinion, Compier PMS, etc. that help to collect, store, and manage data from clinical trials. Information from EDC systems is used to track and report statuses on patient enrollment, study visits completion, completion of eCRFs, data queries, and overall progress of data collection and cleaning.
Clinical Trial Management System (CTMS): All clinical trial activities such as study planning, study documents, subject enrollment statuses, risk management, study budgeting, site monitoring visits, etc. are centrally tracked using our Oracle Siebel CTMS solution.
Randomization and trial supply management systems (RTSM): We use Oracle’s Clinical One platform for managing blinding, subject randomization, and trial supplies management.
Electronic patient reported outcomes (ePRO) systems: Depending on study requirements, we can facilitate the usage of ePRO devices to collect patient-reported outcomes, such as symptoms, quality of life, or functional status. Learn about our partnership with Clario.