Empowering CROs, SMOs & Sponsors Through
Expert Support Services
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.
Comprehensive Partnership Services
Strategic operational support across every phase of clinical development, delivered by specialized teams who work seamlessly with your organization.
Ethics Committee Coordination
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.
- IEC/IRB submission preparation & tracking
- SAE reporting support & documentation
- Amendment coordination & follow-up
- Multi-site ethics committee liaison
Regulatory Affairs Support
Expert assistance with DCGI submissions, regulatory documentation, and compliance support to help your organization navigate India's regulatory landscape successfully.
- CT/IND application preparation support
- Import/export license documentation
- DCGI query response drafting
- Regulatory intelligence & updates
Pharmacovigilance Support
Comprehensive safety monitoring support, SAE case processing, and pharmacovigilance documentation to help ensure patient safety and regulatory compliance for your trials.
- SAE case processing & documentation
- Safety database data entry support
- DSUR/PSUR compilation assistance
- Medical review support & coding
Clinical Data Management
End-to-end data management support from CRF design assistance to database operations, ensuring data integrity and CDISC compliance for your clinical trials.
- eCRF design & database setup support
- Data entry, validation & query resolution
- CDISC SDTM/ADaM mapping support
- Database reconciliation & QC
Biostatistics Support
Statistical consultation, programming support, and analysis assistance that helps transform your clinical data into actionable insights for decision-making.
- SAP review & sample size validation
- Statistical programming (SAS/R)
- TLF generation & validation support
- Statistical analysis assistance
Medical Writing Support
Regulatory-compliant document creation support for protocols, CSRs, IBs, and submission documents that meet global standards and support your approval timelines.
- Protocol & ICF drafting support
- Clinical study report writing
- IB updates & literature review
- Regulatory document preparation
Quality Assurance Support
Independent quality oversight support through audit assistance, TMF management, and quality documentation to help ensure your trials meet ICH-GCP standards.
- Internal audit support & preparation
- TMF organization & maintenance support
- SOP review & training assistance
- Quality documentation support
How We Support Your Success
A proven partnership methodology that ensures seamless collaboration, rapid team integration, and sustained quality throughout your trial lifecycle.
Needs Assessment
We analyze your trial requirements, resource gaps, and timelines to design a tailored support services plan that fits your organization.
Team Integration
Dedicated support specialists with relevant experience are assigned and integrated with your team within 48-72 hours.
Service Delivery
Real-time support delivery with continuous quality monitoring, milestone tracking, and transparent communication with your team.
Quality Review
Independent quality checks, compliance verification, and documentation review before deliverable handover to your organization.
Ongoing Partnership
Continued support with flexible scaling, regulatory updates, and long-term knowledge retention for your programs.
Cross-Functional Expertise Across Therapeutic Areas
Our multidisciplinary teams bring specialized knowledge across major therapeutic areas to support your trial programs.
Oncology
Solid tumors, hematological malignancies, immuno-oncology trials
Cardiology
Heart failure, arrhythmias, atherosclerosis, hypertension studies
Neurology
Alzheimer's, Parkinson's, epilepsy, multiple sclerosis programs
Respiratory
Asthma, COPD, pulmonary fibrosis, rare lung diseases
Diabetes & Metabolism
Type 1/2 diabetes, obesity, metabolic disorders
Rheumatology
RA, osteoarthritis, psoriatic arthritis, lupus trials
Rare Diseases
Orphan drug development, ultra-rare conditions
Infectious Disease
Vaccines, antivirals, antimicrobials, tropical diseases
Why Organizations Choose Prequel as Their Support Partner
We don't just provide services—we become an extension of your team with specialized expertise that accelerates timelines and ensures quality.
Rapid Team Deployment
Support teams operational within 48-72 hours, reducing trial startup bottlenecks by 30-40% and eliminating lengthy hiring cycles.
India Market Expertise
Deep understanding of DCGI processes, established EC relationships, and proven track record supporting trials across India's regulatory landscape.
Quality-First Approach
Every deliverable undergoes independent QC review with documented audit trails, ensuring your trials remain inspection-ready.
Transparent Partnership
Real-time status updates, regular communication, and direct access to our team leads for complete visibility into support operations.
Flexible Resource Scaling
FSP model allows seamless resource scaling up or down based on your trial phase and workload demands without overhead.
Cost-Effective Support
40-50% cost savings vs. in-house hiring while maintaining quality, with pay-for-work-done flexibility.
Traditional In-House Model
- 3-6 month hiring and training cycles
- High fixed overhead and salary costs
- Limited specialized expertise pool
- Resource underutilization between projects
- Continuous training and upskilling burden
- Retention challenges and knowledge loss
Prequel Partnership Model
- 48-72 hour team deployment
- Variable cost with no fixed overhead
- Access to therapeutic area specialists
- Pay only for actual work delivered
- Pre-trained, GCP-certified experts
- Zero retention risk, continuous availability
Compliance Built Into Every Deliverable
Our quality management processes ensure adherence to global standards, with documented procedures, regular training, and continuous improvement protocols that support your compliance requirements.
ICH-GCP Trained
All team members trained in ICH-GCP E6(R2) guidelines
Quality Processes
Documented SOPs and quality procedures
CDISC Standards
SDTM/ADaM data standard implementation support
Audit Ready
Documentation and traceability standards maintained
Ready to Accelerate Your Clinical Trials?
Partner with us to access specialized support services that help your organization execute trials faster, more efficiently, and with greater quality across India.