Our services

  • Project and Site Management
  • Regulatory Development Plan
  • Clinical Protocol Design
  • Informed Consent Form
  • Investigator Brochure
  • Case Report Form
  • Regulatory Affairs
  • Clinical Study Initiation
  • Clinical Coordination
  • Monitoring
  • Data Management
  • Statistical Analysis
  • Data Report
  • Adverse Events Reports and Adjudication

Project and Site Management

Our team manages the project staff for your trial and coordinates the communication between all parties including the investigators, site coordinators, regulatory committee and sponsor.


Depending on the needs of your trial, on-site, remote or risk-based monitoring is performed to ensure protocol and regulatory compliance.

Key Opinion Leaders

RO+ recognizes the importance of working with the “right” scientific advisor to assist our clients in maximizing the potential of their investigational product. Our unsurpassed network of Key Opinion Leaders enables finding the right sites at the right time.

Regulatory Consulting

RO+ provides a full range of regulatory support services for your pre- and post-marketing medical device development needs. Our experts adopt best practices while remaining on top of the ever-changing regulatory landscape, meeting current demands in the following areas:
In-country representation
Legal Representation
EC Authorized Representation
Regulatory submissions
Ethical Committee and Site-level EC submission support
ANVISA and other country-specific review boards
Clinical Safety
Safety Management Plan creation/review
Adverse Event Management
Preparation of Regulatory Reports
Expedited and periodic reporting
Regulatory Compliance Tracking
Data Safety Monitoring Board (DSMB)
and Clinical
Event Committees (CEC) services
Post-Marketing Surveillance (PMS)
Literature and Media Publications Review
Post-Market Clinical Follow-up Studies
Regulatory Medical Writing and Medical Communication
Benefit Risk Assessment Report
Investigator Newsletter
Literature Summary
Risk Management Plan
White Paper