Unlocking Excellence in
Clinical Research
Your Trusted Partner for Global Clinical
Trials and Regulatory Excellence
Promising Best Quality Services
Our Amazing Services
Experience excellence with World Odyssey Healthcare—your go-to for top-tier clinical research support. Elevate your studies with us!
Clinical Trial Management
- E-2-E clinical study management.
- Study & Site Feasibility and training.
- Regulatory Approvals
- Patient Enrolment
- Study Close-out
- Support for Site/ Study Audits, Inspections
Clinical Data Management
- CTD/eCTD Submissions
- Data Management Plan
- CRF Design , Annotations
- Database Design & Validation
- Data Entry & Verification
- Medical Coding
- Discrepancy Management
- AE/SAE Reconciliation
Bio
Statistics
- Statistical Analysis Plan
- Sample Size
Calculation - Interim & Final Analysis
- Randomization Schedule
- Final Statistical
Analysis - Randomization schedule and labelling activities
Clinical Trial Management
- E-2-E clinical study management.
- Study & Site Feasibility and training.
- Regulatory Approvals
- Patient Enrolment
- Study Close-out
- Support for Site/ Study Audits, Inspections
Clinical Data Management
- CTD/eCTD Submissions
- Data Management Plan
- CRF Design , Annotations
- Database Design & Validation
- Data Entry & Verification
- Medical Coding
- Discrepancy Management
- AE/SAE Reconciliation
Medical
Writing
- Study Documents Design including:
- CRF Design
- ICF Design
- Protocol
- Clinical Study Report (CSR)
- NDA Submissions Documentation
- Publication manuscripts
Bio
Statistics
- Statistical Analysis Plan
- Sample Size
Calculation - Interim & Final Analysis
- Randomization Schedule
- Final Statistical
Analysis - Randomization schedule and labelling activities
Regulatory Consulting
- CT Regulatory Submissions and Approvals for India
- venturing into regulatory submissions for FDA and EMA
Medical
Writing
- Study Documents Design including:
- CRF Design
- ICF Design
- Protocol
- Clinical Study Report (CSR)
- NDA Submissions Documentation
- Publication manuscripts
Regulatory Consulting
- CT Regulatory Submissions and Approvals for India
- venturing into regulatory submissions for FDA and EMA
Boost Your Research with Top Services!
Innovative Solutions for Seamless Clinical Research
Our Core Competency
Detailed and process driven SOPs and personnel equipped to provide cost effective services.
Capacity to process and handle Paper / e-CRF and Hybrid studies and Phase I to IV clinical trials, especially in therapeutic areas – Vaccines, Oncology, and CNS.
Our experienced team who have knowledge of all the regulatory requirements and deliver projects on time with adherence to protocol and sponsor requirements.
We have a comprehensive disaster recovery plan designed to keep its extensive information system in act
Pharma pro seeking study support? We've got your back – let's elevate your research game!
Trials on Indications
Promising Best Quality Services
Case Studies By World Odissey
Discover Quick Insights into World Odissey Healthcare's Services
Frequently Asked Questions (FAQs)
Who is World Odissey Healthcare, and what sets it apart in the field of clinical research?
World Odyssey Healthcare is a leading clinical research service provider with a distinguished panel of six qualified medical doctors. What sets us apart is our CEO’s extensive experience in successfully completing over 200 global clinical trials for pharmaceutical giants, along with our core competency in detailed and process-driven SOPs.
What therapeutic areas does World Odissey Healthcare specialize in for clinical trials?
Our expertise spans a range of therapeutic areas, with a particular focus on Vaccines, Oncology, and CNS (Central Nervous System). Our experienced team is well-equipped to handle Phase I to IV clinical trials in these critical health sectors.
How does World Odissey Healthcare ensure client satisfaction and project success?
We prioritize client satisfaction and project success by maintaining a process-driven approach, delivering projects on time, and adhering to protocols and sponsor requirements. Our comprehensive disaster recovery plan ensures the integrity of our extensive information system.
What services does World Odissey Healthcare offer in the realm of clinical research?
Our services encompass Protocol Development, Clinical Data Management, Monitoring/Project Management, ECs & IRBs Approval/Regulatory Affairs, Investigator Selection/Subject Recruitment, and Site Feasibility. We provide end-to-end solutions for successful clinical trials.
Can World Odissey Healthcare assist with regulatory compliance and approvals?
Yes, we offer regulatory services, including the assessment of technical requirements for Drug Master File and CTD preparation. We compile dossiers as per CDSCO Guidance, handle online filing applications, and provide guidance on Recombinant products and Vaccines, collaborating with relevant authorities.
Which regulatory agencies and ministries does World Odissey Healthcare engage with?
We actively engage with regulatory bodies such as ICMR, DBT, RCGM, GEAC, Central Drugs Laboratories, DSIR, State Drug Controller offices, IPC, and NIV, ensuring compliance with all necessary standards and approvals.
How can organizations benefit from partnering with World Odissey Healthcare?
Organizations can benefit from our wealth of experience, expertise, and commitment to delivering cost-effective services. Whether it’s clinical trial management, data management, bio-statistics, medical writing, regulatory consulting, or other clinical services, we are your trusted partner for success.
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