The Biopharma industry is set to take a transformative leap with the rapid adoption of technology-driven scientific development. Techsol offers full-range Clinical Research Services with a focus to deliver high quality, regulatory compliant and cost-effective clinical development results. With our expertise and experience, we partner with sponsors as a trusted scientific solutions provider to bring novel medicines faster to the market.
We have deep scientific, technology and regulatory knowledge to formulate the right study design, selection of a suitable reference product, coordinating with stakeholders, laying pathways for regulatory approvals, completing patient recruitment as per inclusion and exclusion criteria, evaluating statistical considerations based on immunogenicity and safety, timely coordination amongst stakeholders and so on to successfully complete different types of biopharmaceutical clinical trials.
Clinical Research Services
Our team has broad scientific expertise to research, develop, and deliver medical writing services across the clinical development lifecycle. Right from providing knowledge support for the study design of new class of treatments, to expediting the submission and approval of Clinical Trial Applications, we have proven capabilities to provide high-quality scientific content.
- Conducting bridging trials and clamp studies
- Broad knowledge on various therapeutic areas
- Thorough practical experience in crafting medical literature based on Biosimilar guidelines
Establishing the safety profile of a medicinal product is a crucial step and we understand the nuances to get accurate results to account for drug pharmacology (PK/PD), biological activity, maximum tolerated dose (MTD) and so on.
Following are our key specialties for Biopharma clinical studies:
- Toxicology Studies
- Safety Pharmacology Assessment
- Bio-Analytical Services
As a continuum to early phase development, we have the expertise to complete safety assessment, dosage and efficacy determination by conducting Phase I, II and III clinical studies.
With Techsol’s interconnected hospital and healthcare organizations network, we have a broad outreach to a wide-variety of targeted patient populations, qualified principal investigators, and site personnel to timely achieve subject recruitment and complete the study conduct phase in a regulatory compliant manner.
Techsol provides centralized clinical data management services for Phase I to Phase IV clinical studies across various therapeutic areas with a comprehensive risk-based and value-focused data management plan. We are committed to providing the highest data quality, integrity, and security for our clients in meeting 21 CFR part 11, GAMP 5 and HIPAA requirements.
Using industry-leading electronic data capture (EDC) technologies, we provide end-to-end clinical data management support starting from eCRF design to database lock and final study archival.
We have supported clients to execute clinical data management on the following Electronic Data Capture and Medical Coding systems:
- Oracle Inform, Oracle Clinical, Remote Data Capture, Thesaurus Management System
- Medidata Rave, ClinSpark for Early Phase Clinical Trials
We been working for more than 15 years in NDA/ BLA/PMA submission and actively interacting with FDA, EMEA and PMDA working groups.
With an in-depth knowledge on regulatory guidelines such as ICH GCP, ICH E9 and data standards such as CDISC, CDASH and SDTM, our team of SAS Programmers can deliver clean, accurate and enriched data sets that can be be used for determining the safety and efficacy of medicinal products.
Evaluating the readiness state of a regulatory submission requires meticulous planning and continuous team coordination. At Techsol, we have teams unified with our proprietary digital collaboration platform to facilitate fast and streamlined process execution.
Our experience in data submissions, and knowledge of data exchange standards allows fast and accurate data submissions to global regulatory bodies.
With our presence across the globe our global pharmacovigilance team is capable of handling large case volumes, complex multi-center and multi-national safety operations with a combination of offshore and onshore teams. We offer independent PV Services or integrated with global medical information and regulatory services.
Leverage Wearables For Precise Data Collection
Wearable technologies are increasingly adopted to advance the decentralization of clinical trials as conventional methods of data collection must evolve to meet this changing industry landscape. Clinical trial sponsors have an incredible opportunity to increase the precision, quality, and completeness of clinical data by augmenting subjective patient reports and point-in-time clinical outcome data with continuous digital measures.
- Extensive experience in managing different types of biologics clinical studies
- Access to a broad patient pool network
- Deep scientific knowledge that drives risk-based clinical development
- Technology and infrastructure to deliver results in a transparent and regulatory compliant manner
- Designing a strategy apt for the Product Lifecycle
- Knowledge support for the study design of new class of treatments
- Expediting submission and approval of Clinical Trial Applications
- Designing patient recruitment strategies to achieve on-time subject recruitment
- Engaging with patients to eliminate subject dropout
- Eliminating and reducing protocol deviations and non-compliance
- Streamlining on-time site-investigator and vendor payments, staying within budget, payments transparency
- Establishing comprehensive quality, risk, and compliance oversight
- Regulatory compliant source data and trial data management
- Adherence to data standards and applicable regulations
- Support for Clinical Trial Labelling