Planning and Conducting of Phase II-III-IV-Studies

Research & Development RA SA provides professional support to pharmaceutical, biotechnology and medical device industries throughout the entire clinical trial process as defined by the ICH-GCP guidelines and settled in Research & Development RA SA SOPs.

Research & Development RA SA is a provider of Phase II-III-IV clinical research services in Argentina and Latin America.

During the last eight years, our Research Units have provided a full range of quality services, conducting studies across all major therapeutic areas.


Study Planning and Management

Research & Development RA SA offers a full range of high quality services in support of Phase II, III and IV clinical research, including:

• Feasibility surveys
• Clinical development planning (single project or full program)
• Clinical study management
• Protocol writing
• CRF design
• Investigator selection
• Regulatory, Ethics committee and IRB submission support
• Monitoring
• Data management
• Biostatistics
• Medical and scientific writing
• Regulatory affairs
• Post-marketing surveillance
• Quality Assurance Audits
• Pharmacoeconomics
• Quality-of-life studies
• Medical, scientific and regulatory consultation  

Flexibility is the key factor in the relationship between you and Research & Development RA SA . We are happy to meet specific needs, ranging from the individual services listed above to the design and implementation of complete clinical development programs. We tailor our bidding, working and reporting systems to the detailed requirements of each contract.

Research & Development RA SA has come to recognize the importance of the local expertise in its approach to clinical trials.

Our staff is fully aware of the healthcare system, patient referral patterns and pharmaceutical marketplace in the region of Latin America. We have developed extensive local experience and have established relationships with investigators and regulatory authorities. This experience, coupled with a sensitivity to cultural issues, enables us to produce reliable feasibility surveys, ongoing study site motivation, and fast patient recruitment.