FULL-SERVICE CRO|India, UK, USA, EU

End-to-End Clinical Research Partner

One trusted partner for clinical research, regulatory strategy, and evidence generation across every stage of development.

Discuss Research Requirements
✓
Regulatory Strategy Global support
+
Evidence Generation Data-driven research
◉
Global Reach India · UK · USA · EU
Data accepted across leading regulatory markets
US FDA
EMA
Health Canada
UK MHRA
TGA Australia
CDSCO
ANVISA
WHO

Proven CRO Excellence

Regulatory Precision. Global Confidence.

0 +

Years Of Experience

01
0 +

Clinical Trials

02
0 +

BA/BE Studies

03
0 +

Complex Studies

04

Ordoclin Support Full-Service CRO Solutions

Phase I, BA/BE & Medical Device Clinical Trial Expertise

With 21+ years of experience, we support pharmaceutical, biotech, generic drug, and medical device companies through Phase I clinical trials, Bioavailability & Bioequivalence (BA/BE) studies, and Medical Device clinical trial services. By integrating clinical operations, bioanalytical sciences, biometrics, and regulatory processes under one roof, we help partners conduct compliant, scientifically rigorous, and globally accepted development programs aligned with international regulatory standards including FDA, EMA, MHRA, Health Canada, TGA, and CDSCO.

Explore More →

Full-Service CRO Solutions

Phase I, BA/BE & Medical Device Clinical Trial Under One Roof

P-1

Phase I Clinical Trials

Early-phase studies demand precision, oversight, and confidence in every decision. Our Phase I environments are built for programs where safety, PK/PD evaluation, and execution quality are critical.

Key Capabilities
  • + First-in-Human (FIH)
  • + SAD & MAD Studies
  • + PK/PD Investigations
  • + Biosimilar Programs
Explore Phase I →
BA/BE

BA/BE Studies

Bioequivalence data must do more than meet timelines—it must withstand regulatory review. Our BA/BE operations are built around study quality, data integrity, and the consistency required for global submission programs.

Key Capabilities
  • + BA/BE Studies
  • + Healthy & Special Population Studies
  • + GLP-Compliant Bioanalysis
  • + PK Analysis & Biostatistics
Explore BA/BE →
MD

Medical Device Clinical Trials

Clinical evidence is critical in demonstrating device safety, performance, and usability. Our research environments are built for device programs requiring structured clinical evaluation, regulatory alignment, and reliable study execution.

Key Capabilities
  • + Medical Device Clinical Trials
  • + Human Factors & Usability Studies
  • + Combination Product Studies
  • + Device Performance Evaluation
Explore Medical Devices →

Electronic Systems

eCRF — participant specific data capture

CTMS — project and site oversight

eTMF — regulatory-ready document management

LIMS — bioanalytical sample tracking

RTSM / IxRS — electronic randomisation

eConsent — participant consent management

CDISC / CDASH-compliant data standards

Computer systems validation per GAMP 5

Clinical Operations Workflow Under One Roof

Structured workflows supporting drug and medical device trial from protocol to submission.

01

Complex Study Design

Complex study design based on PK /PD comparison.

02

Regulatory Scientific Advice

Advantage of scientific team having expertise of Health authority correspondence for complex study design.

03

Study Feasibility & Protocol Planning

Protocol assessment, study design review, and operational planning.

04

Ethics & Regulatory Approvals

IEC/IRB submissions and regulatory documentation management.

05

Volunteer Recruitment & Screening

Subject identification, screening, and eligibility assessment.

06

Clinical Conduct & Dosing

GCP-compliant study execution, dosing, and safety oversight.

07

PK Sampling & Bioanalysis

Sample collection, processing, and GLP-compliant bioanalytical testing.

08

Data Management & Biometrics

PK analysis, biostatistics, and clinical data evaluation

09

Clinical Reporting & Regulatory Submission

Clinical study reports and submission-ready documentation.

01

Regulatory Strategy & Study Planning

Device classification, intended use, risk profile, clinical evidence requirements, and target regulatory pathways.

02

Clinical Investigation Plan & Regulatory Approvals

CIP preparation and regulatory submissions aligned with global regulatory Standards.

03

Site Selection & Investigator Setup

Selection of qualified investigators, sites, and study teams.

04

Clinical Investigation & Device Evaluation

Device performance, usability, and safety assessments.

05

Data Management & Safety Oversight

Clinical data review, monitoring, and adverse event management.

06

Statistical Analysis & Clinical Documentation

Device performance analysis and regulatory documentation.

07

Clinical Evaluation Report & Regulatory Submission

Clinical Evaluation Reports and submission-ready dossiers.

Discuss your next clinical program.

Contact →