Samahitha Research Solutions
Full-service contract research organization (CRO) and site management organisation (SMO) offering end-to-end clinical development services for drugs, biologics and devices. Services include protocol and study design, clinical operations and monitoring, site management, clinical data management and EDC implementation, biostatistics and analytics, pharmacovigilance/safety reporting, regulatory & medical writing, clinical supply management and pre-clinical study design. Operates offices in India and provides pan-India SMO coverage.
Industries
Nr. of Employees
small (1-50)
Samahitha Research Solutions
Head Office: No. 64, Second floor Old No.1204, New No.04, PID, 121-04, 26th Main Rd, Jayanagara 9th Block, Bengaluru, Karnataka - 560069, India
Products
Medical Writing in Clinical Research
Provides documentation support for clinical trials including study design, protocol development, and clinical study reports.
Regulatory Submission Support
Assists in preparing and submitting regulatory documents, including responses to authorities and licensing support.
Medico-marketing in Clinical Trials
Supports marketing activities related to clinical trials, including regulatory labeling and artwork preparation.
Medical Writing in Clinical Research
Provides documentation support for clinical trials including study design, protocol development, and clinical study reports.
Regulatory Submission Support
Assists in preparing and submitting regulatory documents, including responses to authorities and licensing support.
Medico-marketing in Clinical Trials
Supports marketing activities related to clinical trials, including regulatory labeling and artwork preparation.
Services
End-to-end clinical operations including study design, protocol development, project management, monitoring and study execution support for phase trials, BA/BE and observational studies.
Site feasibility, site staff deployment (CRCs), IRB/IEC submission assistance, IP handling, subject recruitment and retention, SOP preparation and site close-out services.
CRF/EDC design, database build and validation, EDC implementation and training, data entry and validation, query resolution, medical coding and QA.
Statistical consultancy from study inception to reporting, SAP development, sample size calculation, adaptive/Bayesian designs and production of statistical outputs.
Safety data management and reporting, SAE/AE reconciliation, handling of safety databases and PV training.
Preparation of regulatory dossiers, clinical study reports, CTD components, regulatory responses and labeling/artwork support.
End-to-end clinical operations including study design, protocol development, project management, monitoring and study execution support for phase trials, BA/BE and observational studies.
Site feasibility, site staff deployment (CRCs), IRB/IEC submission assistance, IP handling, subject recruitment and retention, SOP preparation and site close-out services.
CRF/EDC design, database build and validation, EDC implementation and training, data entry and validation, query resolution, medical coding and QA.
Statistical consultancy from study inception to reporting, SAP development, sample size calculation, adaptive/Bayesian designs and production of statistical outputs.
Safety data management and reporting, SAE/AE reconciliation, handling of safety databases and PV training.
Preparation of regulatory dossiers, clinical study reports, CTD components, regulatory responses and labeling/artwork support.
Expertise Areas
- Clinical trial management
- Site management (SMO)
- Clinical data management
- Biostatistics and analytics
Key Technologies
- Electronic Data Capture (EDC)
- CDISC SDTM and ADaM standards
- SAS statistical programming
- Adaptive and Bayesian trial designs