OUR SERVICES

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 world 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.

PRE-CLINICAL

Outsourced

Non-GLP

GLP

REGULATORY STRATEGY

Establish a fast-track path to develop a pharma or device asset.

  • Assay development

  • In vitro

  • In vivo

  • Species selection

  • Ames

  • Chronic & Acute tox

CLINICAL TO MARKET

Phase I-FIM

Phase II

Phase III

Post market studies

Medical writing, protocol design and execution to accommodate the strategy defined

 
 

Core Services

Healthcare is experiencing unprecedented changes adding additional pressure to 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. The RARAS suite of services is flexible, accountable, technology-driven and cost-effective.

FEASIBILITY

  • Strategic Consulting

  • Gap Analysis

  • Regulatory  Guidance and Planning

  • Development Planning
    and Design

  • Regulatory agent

  • Submission Planning

  • Recruits & manages patient data via global networks

CLINICAL TRIAL EXECUTION

  • Phase I-IV

  • Site start-up

  • Clinical Monitoring

  • Site Management

  • Project Management

  • SAE and Safety Management

  • Data Management 

POST-MARKETING

  • Registries

  • Post-trials

  • Compassionate Use

  • Real-World Evidenc

MEDICAL WRITING

  • Clinical study protocols

  • Investigator ́s brochure

  • Statistical reports and CSR

  • IND Annual Safety Reports (DSUR)

  • Scientific Publications

  • Manuscripts, Abstracts, Posters

 

Strategic Partners

EDC

  • eCRF

  • ePRO

  • Randomization

ADDITIONAL SERVICES

  • Pre-clinical

  • Phase I and Bioequivalence

  • Storage

  • Clinical Pk/PD

  • Importation and Logistics of IP 

  • Clinical Trial Material sourcing

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.

  • Support a new indication of a registered product

REGULATORY USES

  • Post-marketing safety

  • Support RCT studies when duration or sample is not enough to contextualize safety and efficacy

  • Support changes in dosing, administration or new population

  • Support single-arm trials in Rare Disease or Oncology when a control arm is not ethical or possible

  • Support informed and transparent public and private insurance decisions about prescriptions

CLINICAL RESEARCH USES

  • Assess inclusion/exclusion criteria

  • Study and cohorts geographic distribution

  • Site & patient feasibility

  • Ensure patient diversity and access to clinical trials