Protocol design, IRB liaison, site selection, monitoring, and PER preparation — managed by clinical specialists with deep bioethics expertise.
Why teams choose us
From study design to dossier-ready PER — under one accountable team.
Protocol design, endpoint selection, statistical analysis plan.
Document preparation, submission, and ongoing liaison with ethics bodies.
NABL labs, hospital partners, investigator agreements, site initiation.
GCP-aligned site visits, source data verification, query resolution.
Pre-specified analysis per SAP, interim reports, final clinical study report.
Submission-ready PER with full traceability to source data.
Each milestone is fixed-price and milestone-billable.
Risk class, endpoints, sample size, and target sites confirmed in writing.
CIP, informed consent, case report forms, and statistical analysis plan finalized.
IRB submissions, CDSCO clinical trial permission where required.
Investigator training, source document setup, enrollment monitoring.
Site visits, query resolution, interim reads, database lock.
Final analysis, CSR, and PER compiled per CDSCO format.
PhD-level scientific writing — your protocols and PERs read like top-tier publications.
“The performance evaluation report was thorough and well-traced, which made the regulatory review straightforward.”
Pre-vetted sites with strong GCP track records across India.
Protocols we file are written to be accepted by ethics committees on review.
Endpoints, sample sizes, and analyses defensible to any reviewer.
Performance data accepted on review
A diagnostics manufacturer needed a multi-site clinical performance study for their rapid dengue antigen kit. We designed the study, onboarded NABL labs, ran the sample testing, and compiled the PER.
Multi-site
Clinical study
Defensible
Statistical plan
Accepted
Performance data
Submission-ready
PER dossier
Quick answers about scope, timelines, and how this engagement runs.
Ask us directlyRequired for Class C/D novel devices, devices without a substantial-equivalence predicate, and most active implantables. We assess during discovery.
12–20 weeks for an IVD multicentre study; 6–9 months for a Class C/D device with clinical follow-up.
Yes — fully. We prepare all EC documents, attend meetings if required, and manage every amendment.
Yes, where it meets CDSCO bridging requirements. We’ll advise on whether you need a separate India study or can rely on existing data.
Real-time adverse event reporting, monthly site visits, and an independent data safety monitoring board for higher-risk studies.
A 30-minute scoping call clarifies protocol design, sample size, and timeline — at no cost.