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 * 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:
   
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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


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