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Submission: On April 26 via api from US — Scanned from DE
Effective URL: https://www.orphandc.com/
Submission: On April 26 via api from US — Scanned from DE
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top of page Skip to Main Content * Home * CRO 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 * Commercialization 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 - Brokerage Services - Logistic Support - Market Authorization - Sanitary Vigilance Support - Pricing and Reimbursement Quality Assurance - Supply and Handling Controls - Qualification, Audits, and Inspections * Why LATAM Ethnically Diverse Population High Standard Regulation Medical Infrastructure learn more Untapped Opportunity * Careers 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: learn more * Contact Please feel free to reach out! You can send an e-mail to bd@orphandc.com Or click the button below to learn more about our contact details and send an e-form: learn more CONNECTING PATIENTS TO TREATMENTS, NOVEL THERAPIES, AND CLINICAL TRIALS ODC serves as a partner for biopharma companies to access the large and diverse patient population of Latin America. Our capabilities and expertise are focused on supporting global clients from the clinical development stage throughout the entire product lifecycle. We currently have 60 employees providing services across two verticals: CLINICAL DEVELOPMENT & CRO SERVICES COMMERCIALIZATION & EARLY ACCESS MISSION Provide clinical trial treatment and access for rare and high-complexity patients in Latin America. PURPOSE Provide new clinical trial and treatment access opportunities to our patients and deliver our work with Excellence, Innovation, Commitment, Accountability, and Passion VISION Develop Pharma business in Latin America and advance our clients’ technologies using our local expertise. OUR IMPACT IN NUMBERS 500+ Rare Disease Patients Randomized 25+ Sponsors Phase I/II trials - 35% Phase III/IV trials - 65% 2.6 months Drug Dossier Approval 2.2 months Protocol Dossier Approval (Rare Disease Averages) 3.3 months Drug Dossier Approval 3.4 months Protocol Dossier Approval (General Averages) Learn More NEWS ACCESSIBLE PATIENT COMMUNITIES: A TWO-YEAR EVOLUTION IN LATAM’S RARE DISEASE LANDSCAPE, FOCUS IN BRAZIL, MEXICO, ARGENTINA, AND COLOMBIA FDA REQUIREMENTS FOR DIVERSITY INCLINICAL TRIALS: LATAM OPPORTUNITY BRAZIL AIMS FOR TOP 10 SPOT IN CLINICAL RESEARCH Read All The Latest News BRAZIL São Paulo HQ Rua Quintana, 887 - conj. 144 Cidade Monções, São Paulo/SP CEP 04569-011 Boituva Offices Av. Ver. José Ângelo Biagioni, 660 - sala 44 Boituva Business Park - Centro Boituva/SP | CEP 18550-071 ARGENTINA City of Buenos Aires Blas Parera 3551 Olivos Buenos Aires B1636 COLOMBIA City of Bogotá Calle 81 #11-08 Bogotá 110221 Connect With Us * bd@orphandc.com + 55 11 99449-6491 © 2024 ODC bottom of page