Clinical research support services from feasibility to submission
Prequel Scientific Services LLP provides functional service provider (FSP) support to CROs, SMOs and sponsors in India—covering start-up coordination, site operations & monitoring support, clinical data management, pharmacovigilance, biostatistics/programming, and medical writing—operating under client SOPs and oversight.
- Feasibility & site fit support (48 hrs typical)
- EC/IEC coordination & document readiness
- RBM monitoring support, clean data & on-time DBL
Quality • Compliance • Reliability
Trusted clinical research support partner in India (FSP/Vendor Model)
We support CROs, SMOs and sponsors with SOP-driven processes aligned to ICH-GCP and India’s regulatory pathway expectations. Our teams work under client oversight to keep documentation complete and TMF inspection-ready. We provide EC/DCGI coordination support and dossier preparation as requested; submissions are executed by the sponsor/CRO or by us only when formally authorized.
Our Assurance Pillars
ICH-GCP Alignment
Study conduct, documentation, and oversight mapped to global good-clinical-practice expectations.
EC / DCGI Familiarity
Predictable submissions and responses across CDSCO/DCGI pathways and Ethics Committees.
SOP-Driven Quality
Role-based SOPs, training records, and CAPA discipline to maintain inspection readiness.
Audit-Ready TMF
Health checks, version control, and document governance for clean TMF at closeout.
Standards & Regulatory Frameworks We Operate Within
*Statements describe internal SOP alignment and operating practices; certificates and vendor tools are disclosed under NDA when applicable.
Support Services for CROs, SMOs & Sponsors
Functional service provider (FSP/vendor) support across start-up, site operations, ethics/regulatory coordination, pharmacovigilance, clinical data management, biostatistics & programming, medical writing, and quality/TMF.
Ethics Committee Coordination Support
Document readiness, submissions & responses in coordination with sponsor/CRO.
- Initial submissions & acknowledgements
- Responses to queries & clarifications
- Protocol amendments & renewals
- Continuing review tracking
- Approval documentation & logs
Regulatory Affairs Support (India)
Dossier preparation, trackers & clarifications; filings done by sponsor/CRO or by us when authorized.
- IND/CTA dossiers & IMP import licenses
- DCGI approvals & clarifications
- Responses to deficiency letters
- Post-approval changes/variations
- Regulatory tracking & submissions
Pharmacovigilance Support
ICSR intake/processing, E2B checks, QC & medical review support per client safety SOPs.
- ICSR intake, triage & case processing
- Medical review & quality checks
- E2B(R3) & expedited reporting
- Signal detection & evaluation
- PSUR/DSUR & safety narratives
Clinical Data Management Support
EDC/eCRF build & validation, DMP/edit checks, coding, queries, freeze/lock support.
- EDC/eCRF design & validation (UAT)
- DMP, edit checks & listings
- Medical coding (MedDRA/WHO-Drug)
- Query management & data review
- Freeze & database lock
Biostatistics & Statistical Programming (FSP)
SAP, SDTM/ADaM mapping, TLF programming & QC; submission-ready outputs.
- SAP & sample size/randomization
- SDTM/ADaM mapping & validation
- TLFs programming & QC
- ISS/ISE support & submission packs
- Ad-hoc/statistical consulting
Medical Writing (Vendor)
Protocol/IB, CSR, narratives and statistical sections aligned to TA context.
- Protocol & Investigator’s Brochure
- CSR & synopsis; patient narratives
- SAP & statistical sections
- Informed consent forms
- Safety aggregate contributions
Quality & Audits / TMF Support
Internal/vendor/site audits support, TMF health, deviation/CAPA tracking, inspection readiness.
- Internal, vendor & site audits
- TMF health checks & governance
- Deviation/CAPA lifecycle
- Inspection prep & escort
- SOP management & training
Clinical Trial Management Support
Program coordination from feasibility through closeout under client SOPs.
- Feasibility & site selection
- Start-Up (contracts, budgets, activation)
- Study initiation & oversight
- Risk/issue management & governance
- Closeout & archival
Site Management & Monitoring Support (CRA/CRC)
On-site/remote visit execution, SDV/SDR and follow-ups per the client monitoring plan.
- Monitoring plan, visit schedule
- SDV/SDR & follow-up letters
- Deviation & CAPA tracking
- RBM dashboards & risk signals
- Investigator support
Training & Workshops
Role-based upskilling for sponsors & sites.
- CRA/CRC, CDM, PV, Biostats/SAS
- EC submission workshops
- GCP/GVP refreshers
- Corporate programs
Outcomes Across Supported Studies in India
We focus on measurable clinical research outcomes: faster site activation, disciplined monitoring for clean data, audit-ready TMF, and on-time database locks. The KPIs below guide governance; program-specific SLAs are finalized in your proposal.
Rolling 12 months across similar scopes; final SLAs tailored per protocol.
Parallel EC/contracts workflows to reduce start-up friction.
RBM plans, visit adherence, follow-ups, and issue CAPA closures.
SOP-driven quality system, TMF health checks, inspection readiness.
*Indicative benchmarks from programs we supported as an FSP/vendor; outcomes reflect combined client+vendor execution. Final commitments are documented in the SOW/WO.
How We Work with CROs & SMOs (FSP/Vendor Model)
A standardized, SOP-driven process that keeps governance clear, timelines realistic, and your TMF inspection-ready. We align with ICH-GCP and India’s CDSCO/DCGI pathways while maintaining transparent communication throughout the study.
Discovery & Feasibility
- Protocol synopsis review & risk assessment
- Country/site fit, investigator interest checks
- Feasibility report with timelines & budget bands
Start-Up & EC/DCGI Submissions
- EC/IEC dossier prep & response coordination (approvals managed by sponsor/CRO)
- Contracts, budgets, and site activation readiness
- Study initiation visits & training records
Execution & Oversight
- Monitoring plan (RBM), SDV/SDR, follow-ups
- Data review, query management, safety case flow
- Issue/CAPA governance with KPI dashboards
Closeout & Submission
- Freeze & on-time Database Lock
- CSR & narratives support; TMF health checks (submission executed by client or by us when authorized)
- Archival & inspection readiness support
Governance & Communication
- Dedicated PM, RACI matrix, and RAID log
- Weekly touchpoints and monthly governance reviews
- Risk-based quality oversight and TMF status reporting
Case Highlights (FSP/Vendor Support): Challenge → Approach → Outcome
A few anonymized examples showing how our teams improved start-up speed, monitoring discipline, data quality, and submission readiness across India studies.
Oncology, Phase III — Faster Site Activation
- Challenge: Slow EC/contract cycles delayed FPI.
- Approach: Parallel EC dossiers & budget workflows; pre-init checklists.
- Outcome: FPI in 29 days; visit adherence >95%; on-time DBL.
Medical Device PMS — Safety Case Flow & Signal Hygiene
- Challenge: Inconsistent ICSR triage and delayed follow-ups.
- Approach: Unified intake; E2B(R3) checks; case QC and medical review gates.
- Outcome: <24h expedited compliance; zero late cases over 2 quarters.
Rare Disease, Phase II — SAP → SDTM/ADaM → CSR
- Challenge: Fragmented programming with unclear derivations.
- Approach: Derivation specs; SDTM/ADaM map + double-programmed TLFs; parallel MW.
- Outcome: Clean TLFs pass QC; CSR delivered on schedule.
Capabilities & Tools We Support (FSP/Vendor Model)
We work under sponsor/CRO SOPs and oversight. Our teams integrate with your validated environments to provide execution support across EDC/CDM, Pharmacovigilance, Biostatistics & Programming, TMF/CTMS, and Regulatory/EC coordination. Specific tool stacks are confirmed during onboarding and disclosed under NDA.
EDC & Clinical Data Management Support
We build and maintain study databases under client governance.
- eCRF design & edit checks
- DMP, UAT, listings & reconciliations
- MedDRA/WHO-Drug coding
- Query management & data review
- Freeze & database lock support
Pharmacovigilance & Safety Support
Case processing and aggregate support aligned to client safety SOPs.
- ICSR intake, triage & case processing
- E2B(R3), expedited & follow-ups
- Medical review & QC gates
- Signal detection & evaluation
- PSUR/DSUR contributions
Biostatistics & Statistical Programming
Programming support inside your validated environment.
- SAP, sample size, randomization
- SDTM/ADaM mapping & validation
- TLFs programming & double programming
- ISS/ISE support & submission packs
- Ad-hoc statistical consulting
TMF & CTMS Support
Documentation governance and operational tracking under client QMS.
- TMF setup, filing plans & health checks
- Version control, metadata & QC
- CTMS visit scheduling & action tracking
- Inspection readiness support
- Archival coordination
Regulatory Tracking & EC Coordination
Coordination support with sponsor/CRO as filer of record.
- Dossier preparation & trackers
- Responses to deficiency letters (drafting support)
- Protocol amendments & renewals
- Continuing review & approvals tracking
- Communication logs & documentation
*We operate under client SOPs and licenses. Vendor/tool names are shared during discovery and NDA.
Engagement Models & Onboarding (FSP/Vendor)
We provide functional service provider (FSP) support to CROs, SMOs and sponsors—working inside your validated environments and under your SOPs & oversight. Choose a model below or mix-and-match for scale.
Dedicated FTEs (Onsite / Remote)
Best for throughput & continuity- Role-based allocation (CRA/CRC, CDM, PV, Biostats/SAS, MW)
- Time & materials with agreed SLAs
- Back-up coverage and holiday planning
Project SOW / Work Order
Best for fixed scope & milestones- Defined deliverables and acceptance criteria
- Milestone billing linked to outputs
- Ideal for start-up packets, UATs, TLF batches, CSRs
Hybrid Augmentation
Best for surge & specialized tasks- Blend dedicated FTEs with task-based tickets
- Rapid scale-up/down with monthly governance
- Useful for coding backlogs, narrative bursts, SDV/SDR catch-up
*We operate as a support vendor under client SOPs and licenses. Regulatory filings are performed by the sponsor/CRO, or by us only when expressly authorized in writing.
Your Partner in Research
Our Core Services
We offer a range of specialized services tailored to support your clinical research needs. Our focus is on delivering quality and efficiency, with an emphasis on ease of collaboration. From clinical operations to data management, we ensure that every step of your study runs smoothly.
Clinical Operations
We manage all aspects of clinical studies, ensuring regulatory compliance and site readiness.
Data Management
Our data management solutions optimize the collection and analysis of clinical data efficiently.
Biostatistics
We provide statistical expertise to ensure your study outcomes are valid and actionable.
Client Testimonials
Hear from our clients about their experiences with us.
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ISO Certified Processes
GLP Compliance Verified
ICH GCP Adherence
FDA Approved Protocols
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