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OUR TEAM’S EXPERIENCE PHARMA

Our Team has conducted over 240 projects in 9 countries in Latin America and ha a deep understanding of the cultural differences and regulatory environment.

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.

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FEASIBILITY

  • Strategic Consulting

  • Development Planning and Design

  • Regulatory Strategy and Planning

  • Regulatory agent

  • Submission Planning

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CLINICAL TRIAL EXECUTION  

  • Phase I-IV

  • Site start-up

  • Clinical Monitoring

  • Site Management

  • Project Management

  • Regulatory Affairs

  • SAE and Safety Management

  • Data Management of outsourced services

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REAL WORLD
EVIDENCE (RWE)

  • Registries

  • Post-trials and Compassionate Use

RARE DISEASES

  • MPS I

  • MPS II

  • MPS VII

  • Fabry

  • Gaucher 

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Strategic Partners

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MEDICAL WRITING

  • Clinical study protocols

  • Investigator ́s brochure

  • Statistical reports and CSR

  • IND Annual Safety Reports (DSUR)

  • Scientific Publications

  • Manuscripts, Abstracts, Posters

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CLINICAL TRIAL EXECUTION  

  • eCRF

  • ePRO

  • Randomization

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ADDITIONAL SERVICES

  • Phase I and Bioequivalence

  • Storage

  • Clinical Pk/PD

  • Translations

  • Importation and Logistics of IP & Clinical Research Material

 

SERVICES

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.

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MEDICAL DEVICES

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PHARMA

 

What is Real-World Evidence and Real-World Data? Measure, Analyze, Conclude

WITH SO MUCH IN THE MARKET ABOUT RWE AND RWD, WHY RARAS?

SERVICES

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.

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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