OUR SERVICES
The Regional Raras CRO focuses on reducing the journey of pharmaceutical companies combining smart solutions and unmatched support managing your portfolio from pre-clinical to commercialization.
Our services cover product development , regulatory, clinical trial execution, real word evidence with in-depth expertise in medical device trials.
Product Development
RARAS has designed a launch platform that can take biotech startups from idea to product in the shortest time-to-market possible. RARAS uses its resources in Latin America to launch your development program minimizing risks and generating robust data that can be used for FDA, EMA, ANVISA and other highly regulated agencies registration purposes.
Core Services
Healthcare is experiencing unprecedented changes adding additional pressure in costs, pricing and timelines. Innovation is no longer driven exclusively by traditional players and instead by a multitude of companies with limited resources and underserved by CROs. RARAS suite of services is flexible, accountable, technology-driven and cost-effective.
FEASIBILITY
-
Strategic Consulting
-
Regulatory Strategy and Planning
-
Development Planning and Design
-
Regulatory agent
-
Submission Planning
CLINICAL TRIAL EXECUTION
• Phase I-IV
• Site start-up
• Clinical Monitoring
• Regulatory Affairs
• Project Management
• SAE and Safety Management
• Data Management of outsourced services
REAL WORLD
EVIDENCE (RWE)
-
Registries
-
Post-trials and Compassionate Use
Strategic Partners
MEDICAL WRITING
-
Clinical study protocols
-
Investigator ́s brochure
-
Statistical reports and CSR
-
IND Annual Safety Reports (DSUR)
-
Scientific Publications
-
Manuscripts, Abstracts, Posters
EDC
• eCRF
• ePRO
• Randomization
ADDITIONAL SERVICES
-
Phase I and Bioequivalence
-
Storage
-
Clinical Pk/PD
-
Translations
-
Importation and Logistics of IP & Clinical Research Material
What is Real-World Evidence and Real-World Data? Measure, Analyze, Conclude
WITH SO MUCH IN THE MARKET ABOUT RWE AND RWD, WHY RARAS?
Real-World Evidence and Real-World Data
We collect data related to healthcare or healthcare delivery from different sources, gather it in or own or client’s repository and ensure it is robust enough for publication or regulatory purposes.
REGULATORY USES
-
Support a new indication of a registered product
-
Support changes in dosing, administration or new population
-
Post-marketing safety
-
Support single-arm trials in Rare Disease or Oncology when a control arm is not ethical or possible
-
Support RCT studies when duration or sample is not enough to contextualize safety and efficacy
-
Support informed and transparent public and private insurance decisions about prescriptions
CLINICAL RESEARCH USE
-
Assess inclusion/exclusion criteria
-
Study and its cohorts geographic distribution
-
Site & patient feasibility
-
Ensure patient diversity and access to clinical trials