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Clinical Development
We offer full range of clinical development services in different therapeutic areas for sponsors across the globe with the highest quality, timely deliverables in cost effective budget. Our FSP model deliver end to end clinical trial management right from clinical operations, site management, medical affairs, data management, safety monitoring. We have expert team with 20+ yrs experience, our innovative end to end offerings covers the most challenging aspects of the clinical trials in various therapeutics. Our sponsor can choose the most conventional methodology to advanced technologies in the right manner to address the challenges arises during clinical trial to maximize the project acceptance in global market.
Our capabilities focused mainly in Phase-III, IV clinical trials in oncology, pediatrics, gynecology, urology, nephrology therapeutics.
Our Services
Our end-to-end clinical trials model
Medical Writing
- Trial Design and Protocol Development
- Clinical Summaries, Study Reports, Overviews
- CRFs, ICFs, IB, CSR, Writing
- Risk Management Mitigation Strategy
Site Management (CTMS)
- Site Feasibility and Study Training
- Site Identification, Selection, Qualification
- Patient Screening, Enrollment, IMP Administration
- Site Initiation, Monitoring, Close-out, Follow-up
- Safety Monitoring and Reporting
Biostatistics
- Randomization and Statistical Plan
- CDISC-SDTM, ADaM
- TLFs, ISS/ISE, BIMO
Clinical Data Management (CDM)
- eCRF Design and DM Plan
- Discrepancy, Cleaning Management
- Validation, Locking, Reconciliation
Project Management (PM)
- Clinical Trail Agreement and PM Plan
- Study Planning and Site optimization
- Study Feasibility and Vendor Management
Central Laboratory Services (LIMS)
- Receipt, Storage, Retrieval & Restorage of Samples
- Analysis and Reporting
- Handling and Reconciliation of samples
Pharmacovigilance
- Adverse Events Management
- Signal and Safety Risk Management
- Case Processing and Aggregate Report Writing
- Benefit-Risk Governance
Quality Management System (QMS)
- Internal QA/QC Review Plan
- Prospective and Retrospective Audits
- Data Review and Reporting
- Query and Compliance Management
Non-Clinical Development
Will guide you to select potential CRO for nonclinical development studies which offers safety and efficacy tests for API, Pharmaceutical products, Medical Devices at GLP and OECD compliant, NABL-17025, AAALAC accredited facilities for contract studies
Will guide you to select potential CRO for nonclinical development studies which offers safety and efficacy tests for API, Pharmaceutical products, Medical Devices at GLP and OECD compliant, NABL-17025, AAALAC accredited facilities for contract studies
Non-Clinical Development
We have dedicated team to identify the sites based on the sponsor and regulatory obligations and team comprised of efficient professionals to maximize the patient enrollment, ensuring relevant approvals from authorities and ethics committee
We always focus on the quality outcomes of clinical research and expert in handling site management, trial master file management and Investigator management silos
Bioequivalence Studies
We are in tie up with the top notch CROs working under highly regulated environment those are approved by major regulatory authorities like USFDA, EMEA, ANVISA, NPRA, UKMHRA, Turkey MOH etc.,
we are responsible for right from the site selection, study planning, pilot, pivotal study execution, interpretation of results to till submission final report along with clinical summaries and supporting BE documentation for ANDA dossier
Clinical and Non-Clinical Bioanalysis
We help our clients both in nonclinical and clinical bioanalysis which include central labs for clinical trials sample analysis. Our associated labs are working as per GLP norms under highly regulated environment
We are strong in handling critical sample analysis, our experience is blend of science with an efficiency to take up small, large molecules-LBAs analysis