As your dedicated clinical research accelerator, we provide specialized support services that enable CROs, SMOs, and pharmaceutical sponsors to execute trials faster, more efficiently, and with greater quality across India.
Strategic operational support across every phase of clinical development, delivered by specialized teams who work seamlessly with your organization.
We manage IEC/IRB submissions and approvals on behalf of your organization, leveraging our established relationships with ethics committees across India to accelerate your trial timelines.
Expert assistance with DCGI submissions, regulatory documentation, and compliance support to help your organization navigate India’s regulatory landscape successfully.
Comprehensive safety monitoring support, SAE case processing, and pharmacovigilance documentation to help ensure patient safety and regulatory compliance for your trials.
End-to-end data management support from CRF design assistance to database operations, ensuring data integrity and CDISC compliance for your clinical trials.
Statistical consultation, programming support, and analysis assistance that helps transform your clinical data into actionable insights for decision-making.
Regulatory-compliant document creation support for protocols, CSRs, IBs, and submission documents that meet global standards and support your approval timelines.
Independent quality oversight support through audit assistance, TMF management, and quality documentation to help ensure your trials meet ICH-GCP standards.
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 proven partnership methodology that ensures seamless collaboration, rapid team integration, and sustained 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 within 48-72 hours.
Real-time support delivery with continuous 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 specialized knowledge across major therapeutic areas to support your trial programs.
Solid tumors, hematological malignancies, immuno-oncology trials
Heart failure, arrhythmias, atherosclerosis, hypertension studies
Alzheimer’s, Parkinson’s, epilepsy, multiple sclerosis programs
Asthma, COPD, pulmonary fibrosis, rare lung diseases
Type 1/2 diabetes, obesity, metabolic disorders
RA, osteoarthritis, psoriatic arthritis, lupus trials
Orphan drug development, ultra-rare conditions
Vaccines, antivirals, antimicrobials, tropical diseases
We don’t just provide services—we become an extension of your team with specialized expertise that accelerates timelines and ensures quality.
Support teams operational within 48-72 hours, reducing trial startup bottlenecks by 30-40% and eliminating lengthy hiring cycles.
Deep understanding of DCGI processes, established EC relationships, and proven track record supporting trials across India’s regulatory landscape.
Every deliverable undergoes independent QC review with documented audit trails, ensuring your trials remain inspection-ready.
Real-time status updates, regular communication, and direct access to our team leads for complete visibility into support operations.
FSP model allows seamless resource scaling up or down based on your trial phase and workload demands without overhead.
40-50% cost savings vs. in-house hiring while maintaining quality, with pay-for-work-done flexibility.
Our quality management processes ensure adherence to global standards, with documented procedures, regular training, and continuous improvement protocols that support your compliance requirements.
All team members trained in ICH-GCP E6(R2) 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 to access specialized support services that help your organization execute trials faster, more efficiently, and with greater quality across India.
