FULL SERVICE CRO

JCDC is a fast growing, global, clinical-stage full service CRO. We provide end-to-end services for Phase I-IV clinical trials, Validation studies, Real World Evidence (RWE) Studies or Biobanking projects.

JCDC expertise is in Medical Writing, Monitoring and Project Management, Clinical Data Management, Biostatistics and Site Management.

What makes us unique is our digital transformation and early adoption of decentralized clinical trials, which have allowed us to conduct clinical trials with minimum manual/paper processes and reduced the need for physical travel to sites. This results in significant cost and time savings for our clients.

Our multi-disciplinary team (including clinicians, researchers, regulatory and operational experts), hands-on approach, flexibility and complete transparency allows us to offer you customized solutions and study designs for your clinical trial’s success.

Study Design
Operations Support
Data Management
Statistical Analysis
Clinical Writing

Study
Conceptualization



Regulatory
Pathway Guidance


Study design, including statistical design and sample size calculation


Protocol
synopsis

Site
identification



Subject
identification


Negotiate
site Contracts, IRB
approvals


Site trainings and initiation

Database design/ develop Data layout:



Data
capture



Data
validation


Deliver analysis-ready dataset

Statistical Analysis Plan (SAP)



Programming and data analysis


Statistical study report





Protocol



Informed Consent Form (ICF)


Study reports



 

Study Design and
Reg Pathway

Study Design and
Reg Pathway

Study Design and
Reg Pathway

Study Design and
Reg Pathway

Study Design and
Reg Pathway

Study Design

Study Design

Study Design

Study Design

Study Design

Study Conceptualization



Regulatory Pathway Guidance



Study Conceptualization



Regulatory Pathway Guidance


Study Conceptualization



Regulatory Pathway Guidance



Study Conceptualization



Regulatory Pathway Guidance


Study Conceptualization



Regulatory Pathway Guidance



Study Conceptualization



Regulatory Pathway Guidance


Study Conceptualization



Regulatory Pathway Guidance



Study Conceptualization



Regulatory Pathway Guidance


Study Conceptualization



Regulatory Pathway Guidance



Study Conceptualization



Regulatory Pathway Guidance


Service Provided as a CRO
Medical
Writing
Clinical Operations: Monitoring, Project Management
Data Management & Biostatistics
Regulatory
services
Clinical Study document preparation: Protocol, Manuscript, Informed
Consent Form,
Study reports. Literature
review and
Meta-analysis

Based on years
of Clinical
Operations experience
at the Site level

 

End to End Data
Management and Biostatistics services
from Study startup, study conduct and Close Out
Availability of 21 CFR Part 11 compliant EDC platforms

Regulatory Consulting including regulatory pathway to US FDA, EMEA and MHRA.

Central Ethics committee
services

  • Focus Areas as a CRO
    Phase 1 – 4 Clinical Trials
  • Real World Evidence Studies
  • Post Marketing Surveillance (PMS) Studies
  • Observational / Registry Studies
  • Pilot and Pivotal Validation Studies
  • Safety & Efficacy Testing Services for Medical Devices
  • Claims Support Studies Safety & Efficacy Testing Services Ffor Cosmetics, Dermaceutical, OTC and Phyto-Pharmaceutical Products
  • Nutrition Studies Glycemic Index, Growth& immunity, Bone Health, Cognitive Functions, Obesity, Metabolic disorders, Gastrointestinal Disorders etc