Clinical research ward with monitored study beds at the Celesta Healthcare clinical research centre
Clinical Research Division · ICH-GCP Compliant

Patient-Based Clinical Trials

Comprehensive Phase I–IV clinical trial services for pharmaceutical, biotech, and medical device companies — from protocol design and site selection to data delivery, with patient safety at the centre.

Phase I–IV
Full Lifecycle
Coverage
Pan-India
Investigator &
Site Network
ICH-GCP
E6 (R3)
Compliant
70+
Years Cumulative
Team Experience
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Overview

Clinical Trials, Managed End to End

Our clinical trials team supports the entire lifecycle of a study — from early-phase trials to late-stage clinical development and post-marketing surveillance. Sponsors get a single accountable partner for protocol development, regulatory submissions, site management, patient recruitment, monitoring, data management, and biostatistics.

Every trial runs on three non-negotiables: patient safety,regulatory compliance, andtimely, reliable data. That is how studies stay on schedule and submissions stay defensible.

Coverage

Phase I to Phase IV — Under One Roof

Phase I

Safety & Pharmacokinetics

First-in-human and early-phase studies establishing safety profile, tolerability, and PK behaviour.

Phase II

Proof of Concept

Dose-ranging and preliminary efficacy studies in patient populations with the target condition.

Phase III

Pivotal Efficacy Trials

Large multi-site confirmatory trials generating the efficacy and safety evidence for approval.

Phase IV

Post-Marketing Surveillance

Real-world safety monitoring and evidence generation after the product reaches the market.

Services

Everything a Sponsor Needs

Six integrated service lines that carry a study from first protocol draft to final statistical report.

Study Design & Protocol Development

Protocols built with sponsors around the study goals — scientifically rigorous, statistically sound, and regulator-ready.

Regulatory Strategy & Submission

Guidance through regulatory requirements and complete submission management with the authorities.

Site Selection & Management

A strong pan-India network of experienced investigators and sites across therapeutic areas.

Patient Recruitment & Retention

Targeted recruitment strategies and retention programs that keep enrolment on schedule and studies continuous.

Data Management

Accurate, timely, and secure data collection and cleaning on validated tools — quality and compliance built in.

Statistical Analysis

Comprehensive biostatistics — analysis plans, exploratory analyses, and modeling that support decisions and submissions.

Patient First

Safety Is the Study Design

Independent ethics committee oversight, rigorous informed consent, trained investigators, continuous medical monitoring, and disciplined adverse event reporting are built into every protocol — because credible data can only come from trials that protect the people in them.

Clinical Infrastructure

Built for Safe, Monitored Studies

Real photographs from our clinical research centre — medical monitoring, participant screening, and laboratory infrastructure behind every trial.

Medical monitoring room with hospital beds, patient monitors, and emergency equipment
Medical Monitoring & Emergency Care Unit
X-ray room used for participant screening at the clinical research facility
Participant Screening — X-Ray Room
Laboratory benches with sample processing area at the clinical research facility
Sample Processing Laboratory
Why Celesta

One Partner, Full Accountability

  • Phase I–IV coverage under one accountable partner
  • Pan-India investigator and site network across therapeutic areas
  • ICH-GCP (E6 R3) compliant conduct with ethics oversight
  • Pharma, biotech, and medical device sponsors supported
  • Validated data management systems and audit trails
  • In-house biostatistics and medical writing teams
  • Regulatory submissions handled end to end
  • Patient safety and data integrity above all
FAQs

Clinical Trials — Frequently Asked Questions

1. Which clinical trial phases do you manage?
We support the full clinical development lifecycle — Phase I through Phase IV. That includes early-phase safety and PK studies, pivotal Phase III efficacy trials, and post-marketing (Phase IV) surveillance studies, for pharmaceutical, biotech, and medical device companies.
2. What is a patient-based clinical trial?
Unlike healthy volunteer studies, patient-based trials enrol participants who have the condition the drug is intended to treat. They are required when dosing healthy volunteers is inappropriate (for example oncology or chronic disease therapies) and for demonstrating real therapeutic efficacy and safety.
3. How do you recruit and retain trial participants?
We run targeted recruitment strategies through our pan-India network of investigators and sites across therapeutic areas, combined with structured retention programs — so studies enrol eligible participants on schedule and maintain continuity through the last visit.
4. How is patient safety ensured during a trial?
Every study operates under ICH-GCP (E6 R3) with independent ethics committee oversight, informed consent, trained investigators, medical monitoring, and defined adverse event reporting workflows. Patient safety and data integrity take precedence over timelines, always.
5. What data management and statistics support do you provide?
Our data management team runs validated tools for accurate, secure, and compliant data collection and cleaning, while our biostatisticians deliver statistical analysis plans, exploratory analyses, and statistical modeling to support submissions and decision-making.
6. Do you also handle the regulatory submissions for trials?
Yes. Our regulatory affairs team manages regulatory strategy and submissions to authorities — from clinical trial applications through post-approval commitments — so sponsors work with a single accountable partner.
7. How are clinical trials regulated in India?
Clinical trials in India are governed by the New Drugs and Clinical Trials Rules, 2019 (NDCT Rules) under CDSCO, with approval from the Drugs Controller General of India (DCGI) and registered ethics committee oversight. The rules define a 90-working-day timeline for clinical trial application review, making India one of the more predictable trial destinations.

Explore Our Other Clinical Research Services

One research partner from first protocol draft to final approval — every service under one roof.

BA/BE Studies

Bioavailability & bioequivalence studies with LC-MS/MS bioanalysis for regulated markets.

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Medical Writing

Protocols, CSRs, dossier documents, and publications aligned to ICH, FDA, and EMA.

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Regulatory Affairs

Submission strategy and lifecycle support across US, Europe, Asia, and Brazil.

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Have a Study to Run?

Tell us the indication and the target market — our clinical team will map out the phases, sites, and timeline with you.

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