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.
Monitoring
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
Legal Representation
EC Authorized Representation
Regulatory submissions
Ethical Committee and Site-level EC submission support
ANVISA and other country-specific review boards
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
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
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
Manuscript
Narratives
Risk Management Plan
White Paper
Benefit Risk Assessment Report
Investigator Newsletter
Literature Summary
Manuscript
Narratives
Risk Management Plan
White Paper