As your clinical research support partner, we provide specialized support services that help CROs, SMOs, and pharmaceutical sponsors execute trials efficiently and to standard across India.
Strategic operational support across the phases of clinical development, delivered by specialized teams who work seamlessly with your organization.
We prepare and coordinate IEC/IRB submissions on behalf of your organization, working with ethics committees across India to keep approvals moving.
Expert assistance with CDSCO submissions, regulatory documentation, and compliance support to help your organization navigate India’s regulatory landscape.
Comprehensive safety monitoring support, SAE case processing, and pharmacovigilance documentation, supporting patient safety and regulatory compliance in your trials.
End-to-end data management support from CRF design assistance to database operations, supporting data integrity and CDISC-conformant deliveries for your clinical trials.
Statistical consultation, programming support, and analysis assistance that helps transform your clinical data into actionable insights for decision-making.
Document preparation support for protocols, CSRs, IBs, and submission documents, written to ICH and the applicable regulatory guidelines.
Independent quality oversight support through audit assistance, TMF management, and quality documentation, supporting your trials’ alignment with ICH-GCP.
Program coordination from feasibility through closeout under client SOPs.
On-site/remote visit execution, SDV/SDR and follow-ups per the client monitoring plan.
In-house team training for sponsors, CROs and sites. Individual career courses are run by BCRI.
A structured way of working, from needs assessment to ongoing partnership, built for clear collaboration and consistent quality throughout your trial lifecycle.
We analyze your trial requirements, resource gaps, and timelines to design a tailored support services plan that fits your organization.
Dedicated support specialists with relevant experience are assigned and integrated with your team to the timeline set in the work order.
Support delivered with ongoing quality monitoring, milestone tracking, and transparent communication with your team.
Independent quality checks, compliance verification, and documentation review before deliverable handover to your organization.
Continued support with flexible scaling, regulatory updates, and long-term knowledge retention for your programs.
Our multidisciplinary teams bring experience in the following areas to support your trial programs.
Clinical research support for oncology programmes
Support for rare-disease and orphan-drug programmes
Clinical evidence and investigation support for devices
Pharmacovigilance and safety reporting after approval
We don’t just provide services—we work as an extension of your team, bringing specialized expertise to your timelines and quality standards.
Support teams become operational quickly because they are already trained, which takes the hiring cycle off your startup critical path.
Experience with CDSCO processes and ethics committee requirements, and direct experience supporting trials across India’s regulatory landscape.
Independent QC review built into delivery, with documented audit trails supporting your trials’ inspection readiness.
Regular status updates, open communication, and direct access to our team leads for clear visibility into support operations.
FSP model allows resource scaling up or down based on your trial phase and workload demands, without carrying fixed headcount.
Pay for work done rather than carrying permanent headcount, without trading away quality.
Our quality management processes are built around the applicable international standards, with documented procedures, regular training, and continuous improvement that support your compliance requirements.
All team members trained in ICH-GCP E6(R3) guidelines
Documented SOPs and quality procedures
SDTM/ADaM data standard implementation support
Documentation and traceability standards maintained
*Statements describe internal SOP alignment and operating practices; certificates and vendor tools are disclosed under NDA when applicable.
Partner with us for specialized support services that help your organization execute trials efficiently and to standard across India.
