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Clinical Operation : Clinical Research is an expensive, time-consuming and an arduous process. A strong team backed with experience and scientific knowledge can make this process worth it. Our Clinical Operations Team is well-trained and serves as a strong link between the Sponsor & the various Service Providers for material and information transactions. Our Clinical Operations involve,
Study Feasibility : The Clinical Study Feasibility Analysis and Site Selection are the basis of any successful clinical trial. The Feasibility Analysis gives the Trial Sponsor an insight into our project management capabilities. Our custom designed Questionnaires and processes are effective in predicting site success for a trial. This feasibility helps Sponsor assess the deliverables, timelines, responsibilities and projected risks involved in the project.
Project Management & Planning : Our Project Management team has prime focus on time-lines, cost effectiveness and quality trials. In one word, we understand the concerns of our clients.
- Our qualified managers, CRAs and CRCs have in-depth knowledge of ICH GCP guidelines and regulatory requirements for conduct of clinical trials.
- Our experienced project management team can predict & plan for the uncertainties thus reducing the risks involved in project.
- Project Managers take on the responsibility of being the sole point of contact, relaying information and reporting on a continuous basis.
- We establishnew sites to increase patient recruitment rates and reduce operational costs. Hence, quality at an affordable cost is the deal at THS.
Clinical Monitoring : We have a dedicated clinical monitoring team of CTLs /Sr.CRAs / CRAs /CRCs. Monitors ensure ICH-GCP compliance & data integrity at each site visit and retrieval of high quality and on-time data. The Clinical monitoring team ensures the adherence to SOPs and strives to promote personal relationships with a high level of trust and confidence with all our investigators and other project participants. Our Monitors perform 100% Source Document Verification of the captured data and thus guarantee accurate and reliable data.
IMP Management : We have innovative Packing, Good Packaging, Labeling, Storage and transportation facilities according to GMP to support your product's clinical trial program.
- GMP facility that can provide fast & efficient manufacturing of solid dosage, liquids, creams and ointments
- Closed controlled logistics and product tracking system
Biostatistics : Our Biostatistics services include:
- Clinical trial design (Blinding & Randomization)
- Sample Size calculation
- Writing statistical analysis plans
- Planning and implementation of interim analysis
- Final statistical analysis using SAS
- Writing statistical reports
Medical Reporting : THS offers to undertake the complete Medical Monitoring of Phase Trials
- Serious Adverse Event (SAE) form and safety database design and development
- SAE collection, evaluation, classification, and reporting
- Medical case reviews
- Adverse event narration and coding
- Comprehensive, Pharmacovigilance and safety surveillance services
Medical Writing : We, at THS, provide the following documentation in accordance with ICH and other applicable guidelines:
- Study Design / Outline
- Investigators' Brochure (IB)
- Protocol & Protocol amendments
- Informed Consent Document
- Patient Diary and Subject Emergency Card
- Clinical/statistical study report
- Publication support
We understand the need for fully integrated clinical study reports fulfilling all global regulatory & ICH-E3 requirements.
Regulatory Affairs : Approvals and liaison with Indian Regulator the Drug Controller of India is taken care by THS, while we partner with our collaborator Amarex Clinical Research, USA for FDA submissions. Our regulatory service includes:
- Strategic regulatory planning for specific countries
- Pre-IND meetings
- INDs
- NDA & ANDA
- Applications for marketing license
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