CRO Business | Contract Research Services

Equipped with pioneering infrastructure, purpose-built facilities, and advanced analytical platforms, Cadila CRO offers end-to-end research solutions, from protocol development and site management to bioanalytical testing and statistical analysis to study report delivery.

Established in 2003 and fully operational by 2005, Cadila CRO (DCGI-approved) is a reputable Clinical Research Organisation dedicated to advancing drug development through high-quality, ethical, and compliant research services. With more than twenty years of experience, we focus on Bioavailability/Bioequivalence (BA/BE) studies, Phase I-IV clinical trials, and pre-clinical research. We support pharmaceutical and biotech companies worldwide in their efforts to introduce safe and effective therapies to the market.

At the core of our operations is a commitment to scientific excellence, regulatory integrity, and patient safety. Our diverse team of experienced professionals collaborate to deliver reliable, timely results that align with global regulatory standards.

We partner with global sponsors to deliver personalised clinical development support backed by strong quality systems and a proactive, end-to-end approach across BA/BE, Phase-I, clinical trials, and pre-clinical studies.

Our Vision

To be a leader in advancing medical science by delivering innovative, ethical, and reliable pre-clinical and clinical research solutions.

Our Mission

To conduct ethical and transparent pre-clinical and clinical studies that bring safe and effective treatments to market while upholding the highest standards of care and integrity.

With extensive experience in successfully conducting Bioavailability and Bioequivalence (BA/BE) studies, our CRO remains a leader in clinical research excellence. We specialise in providing high-quality, compliant, and timely services that adhere to the strict standards of global regulatory agencies.

We offer end-to-end support for BA/BE studies across a wide range of therapeutic areas and dosage forms, from immediate- and modified-release formulations to complex generics.

2 clinical units consisting of a 66-bed facility
2 fully equipped ICUs with cardiac monitors
Deep freezers, secured pharmacy with power backup
Well-equipped basic life support ambulance for the critical care of subjects
Dedicated facility for the storage and processing of biological samples
Healthy Subject Database of > 11000 volunteers
Online Volunteers Information Biometric System to avoid cross-participation of subjects

Pharmacokinetic (PK) and Statistical Analysis

2 clinical units consisting of a 66-bed facility
2 fully equipped ICUs with cardiac monitors
Deep freezers, secured pharmacy with power backup
Well-equipped basic life support ambulance for the critical care of subjects
Dedicated facility for the storage and processing of biological samples
Healthy Subject Database of > 11000 volunteers
Online Volunteers Information Biometric System to avoid cross-participation of subjects

We specialise in delivering end-to-end clinical trial services designed to support sponsors across every phase of drug development. With a commitment to scientific integrity, regulatory compliance, and operational excellence, our multidisciplinary team ensures the execution of clinical trials, from planning through submission.

Clinical Operations

From site selection to study close-out, our clinical operations team ensures trials are executed on time, within budget, and to the highest quality standards. We offer robust project management, site training, feasibility assessments, monitoring, and risk-based quality oversight tailored to your study needs

End-to-End Trial Management -Site selection, initiation, monitoring, and close-out.
Regulatory and GCP Compliance -Adherence to global standards and guidelines.
Efficient Site Communication -Coordination among sites, investigators and sponsors.
Timely Milestone Delivery -Proactive project management to ensure on-time trial completion.

Medical Monitoring

Our experienced team provides continuous medical oversight to ensure participant safety and data accuracy throughout your trial. We offer real-time clinical assessments, protocol compliance support, and adverse event management, all aligned with global regulatory standards.

Ensures Subject Safety - Continuous oversight to ensure participant safety and well-being throughout the trial.
Clinical Oversight - Real-time review of adverse events, protocol deviations, and serious adverse events.
Medical Expertise - Involvement of qualified physicians to guide and support clinical decision-making.
Risk Mitigation - Early identification of safety signals and implementation of corrective measures.

Medical Writing

Clear, compliant, and scientifically sound documentation is critical to trial success. Our medical writers develop a full range of clinical documents, including protocols, investigator brochures, clinical study reports (CSRs), and regulatory submission dossiers. Every document is crafted with precision, ensuring clarity and consistency.

Regulatory-Compliant Documentation - Preparation of protocols, investigator brochures and CSRs.
Consistency & Clarity - Ensures scientific accuracy, clarity, and consistency across documents.
Support for Publications - Manuscripts, abstracts, and posters for scientific dissemination.
CustomisationTailored documents to meet sponsor and regulatory authority expectations.

Data Management

Accurate, clean, and regulatory-ready data is at the heart of every successful trial. We provide comprehensive data management solutions, including EDC setup, CRF design, data validation, query resolution, and database lock, all compliant with CDISC, ICH-GCP, and 21 CFR Part 11.

High-Quality Data Capture - Design and implementation of robust eCRFs and EDC systems.
Data Integrity and Cleaning - Real-time data validation, query resolution, and cleaning processes.
Regulatory Ready Datasets - CDISC-compliant data formats (SDTM, ADaM) for submission.

Biostatistics

Our biostatistical experts bring analytical rigour to your trial design and data interpretation. From sample size calculations to advanced statistical modelling and analysis, we ensure your results are scientifically defensible and regulatory-ready, accelerating your path to market.

Robust Study Design - Sample size calculation, randomisation schemes, and statistical plans.
Interim and Final Analyses - Comprehensive statistical analyses for efficacy and safety outcomes.
Regulatory Submission Support - Preparation of statistical sections for regulatory dossiers.
Advanced Methodologies - Use of innovative statistical models for complex trial designs.

Regulatory Inspections (BA/BE)

Our commitment to quality and compliance is reflected in our successful inspection history with leading global regulatory authorities. We have undergone multiple audits by:

For Bioavailability/Bioequivalence (BA/BE)

For Clinical Trial & Patient BA/BE

These inspections have consistently affirmed our adherence to international Good Clinical Practice (GCP) and regulatory standards, reinforcing our reputation as a trusted partner in clinical research.

Quality Assurance

Cadila CRO is dedicated to providing data of the highest quality and authenticity for every project. The RQA audit, an integral part of the Quality System at our site, is conducted at every critical stage of the study.

Features:

Quality Assurance capabilities covering GXPs and other regulatory requirement(s).
Experienced team with expertise across all aspects of QA in the field of Pre-clinical, Clinical (BA/BE), Bioanalytical, Clinical Trials, Data Management, Statistical Analysis and Medical Writing.
Executed audits for Clinical Trials sites and laboratories across India for various in-house and sponsor studies.
Flexible and Responsive service with tailored solutions to suit the sponsor's needs.
Assurance of Compliance from initiation to final report submission and issuing a final QA statement.

QA Services:

Quality Assurance Consulting
Establishment of a QA system for GCP/GLP
Quality Management System planning and implementation
Development of Policies and SOPs
Prospective, online and retrospective audits
Internal system/facility audits
External Audits-Routine Audits, sponsored, directed site audits and vendor audits
Post Audit Support-Process Improvement implementation and system upgradation
Ensure sponsor and regulatory inspection readiness

Our Quality Assurance Team is an independent function. It ensures that the conduct of the Clinical and Pre-clinical studies, including the generation, documentation, and reporting of data, complies with the Protocol, Good Clinical Practices, Good Laboratory Practice standards, and applicable regulatory requirements.

All steps involved in data management are documented to demonstrate the measurement of qualitative data and the performance of the clinical study. The documentation is facilitated by methods such as checklists and forms, and includes details of actions taken.

The state-of-the-art OECD GLP-certified Pre-Clinical facility is spread over 5600 sq. ft. of laboratory space, in the sprawling, beautiful campus of Cadila. The animal house is designed in accordance with GLP & CPCSEA requirements.

The salient features of the animal house are: a double-corridor facility to ensure unidirectional flow of material, 100% exhaust in the breeding facility (no recirculation of air), and automated illumination, with 12 hours of lighting in a 24-hour cycle. The movement of material within the facility strictly follows the unidirectional flow.

Human Assets

Area of Expertise

Regulatory and Other Approvals

The success of Pre-Clinical is the result of the efforts of highly motivated, dedicated scientific and supporting personnel. A well-defined organisational structure with strong leadership ensures the benefits for both the sponsor and the Pre-Clinical CRO. Regular SOP and other internal and external trainings lead to continuous strengthening of personnel skills in science and regulatory requirements in their field of activities.

CDMO Partner

Partner With Cadila CRO

Accelerating Innovation With End-to-End CRO Excellence

Precision, transparency, and research you can trust

Trusted expertise in BA/BE and Phase-I

Clinical trials delivered with precision