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!
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