Site Selection
- Pre-feasibility - Environmental assessment - Patient Journey Overview - Sites Recommendation - Sites Selection / Qualification visit
Monitoring Activities
- Site Initiation Visits (SIV)​ - Interim Monitoring
Visits (IMV)​ - Close-Out Visits (COV)​ - Site Management
Startup/Regulatory
- Protocol and Investigator Brochure​ - Informed Consent Form (ICF)​ - CRF/eCRF​ - Identify and Recruit Investigational Sites​ - Qualify Sites​ - Randomization Services​ - Study Medication Management​ - Management of Other Clinical Supplies​ - Electronic Trial Master File​ - Regulatory Gap Analysis & Submissions - Ethical Submissions
Patient Recruitment
- Patient Support Program - Medical monitor review for pre-screening - Support for patient identification - Engagement of sites and referral institutions - Medical education and disease awareness initiatives - Meaningful reduction of the gap between site activation and FPI - Patient concierge services
Therapeutic Areas
- Rare Diseases - Cell and Gene Therapy - Oncology - Infectious Diseases - Hematology - Ophthalmology - Nephrology - Neurology - Cardiovascular - GI and Hepatology - Endocrinology - Allergy and Respiratory - Rheumatology
Expertise
Early Access
Commercialization
Regulatory Hosting
-Rare and Ultrarare Diseases
-High Complexity Diseases
- Post Trial Supply
- Patient Help Desk (PHD Program)
- Importation Support
- Brokerage Services
- Logistic Support
- Patient Support Program
- Diagnosis Support Program
- Pharmacovigilance
- Importation & Exportation Support
- Market Authorization - Sanitary Vigilance Support - Pricing and Reimbursement
Quality Assurance
- Supply and Handling Controls - Qualification, Audits, and Inspections
Ethnically
Diverse Population
High Standard Regulation
Medical Infrastructure
Untapped Opportunity
Empowering Progress in Healthcare
Our mission is to enact positive change for patients.
Come join our team!
Click the button below to learn more about open positions and send your CV:
Please feel free to reach out!
You can send an e-mail to bd@odclifesciences.com
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