Research & Development RA
 | |
| | |
| Research & Development RA SA | |
|---|---|
| Type | Private |
| Industry | Research |
| Founded | 1993 |
| Headquarters | CABA, Buenos Aires |
| Number of employees | 11-50 |
Contents
- 1 History
- 2 MISSION & VISION
- 3 SERVICES
- 3.1 CLINICAL TRIAL SERVICES, PHASES I TO IV
- 3.1.1 Clinical Study Feasibilities
- 3.1.2 Project Management and Strategic Planning
- 3.1.3 Regulatory Study Management
- 3.1.4 Clinical Trial Monitoring
- 3.1.5 Safety and Pharmacovigilance
- 3.1.6 Quality Assurance
- 3.1.7 Patient Recruitment and Retention Services
- 3.1.8 Vendor Evaluation, Qualification and Oversight
- 3.1.9 Development of Study Documents
- 3.1.10 Data Management
- 3.1.11 Statistics
- 3.1.12 Medical Writing
- 3.2 BIOEQUIVALENCE STUDIES
- 3.3 PRODUCT REGISTRATION
- 3.1 CLINICAL TRIAL SERVICES, PHASES I TO IV
History
Research & Development RA SA CRO is a full-service contract research organization based in Buenos Aires, Argentina. It was founded in 1993 as a family enterprise, by Santiago Liuboschitz, MD and his son, Pablo Liuboschitz, BsC.
Research & Development CRO has been operating in the Latin American market for more than 20 years. Considering that the first regulation for clinical trials in Latin America was approved in 1997 in Argentina, it is easy to see that Research & Development CRO has been active and present since the very beginning.
Dr. Santiago had developed his career since 1972 within the pharmaceutical industry, after 10 years of medical practice. He had started off as Medical Director at Merck Sharp & Dhome where he stayed until 1980, was later the Head of Clinical Research at Ciba-Geigy Argentina until 1992 and finally was the Southern Cone Regional Medical Director at SmithKline Beecham until 2000.
He was Research & Development’s CEO until 2008 and is currently the Vice-President. Pablo Liuboschitz, was a Bachelor in Science at that time, and he began to work in clinical research in 1995. He was a researcher, later became a CRA and clinical research advisor and finally was the Clinical Research Manager of Research & Development CRO. After completing a Master in Business Administration he took over the CEO position in 2008.
In 2000, Research & Development was able to expand their services to Brazil. In 2001 expansion reached Mexico, Costa Rica and Chile. In 2009 Uruguay was included as well and in 2014 through a Clinical Research Consortium composed of 8 other CROs we are now able to go global with clinical trials, offering outstanding quality and local “know-how” within affordable budgets.
We can provide full support for bioequivalence studies, clinical trials from phase I to IV and product registration. Our client list includes small and medium-sized biotech companies, national and multinational pharmaceutical companies and CROs. For disclosure of Client List please contact us. Research & Development CRO is the first national member of CAOIC [http://www.caoic.org.ar/], the Argentine Chamber of CROs.
MISSION & VISION
Our Mission is to provide professional, cost- effective and timely assistance to our Clients to contribute to their drug development efforts and to guarantee the collection of high-quality clinical data in Latin America, in compliance with research ethics, international standards and local regulations that warrant subject protection.
Through our strong project management skills, proactivity, local expertise, flexibility and integrity we commit to achieve and exceed the client’s expectations for individual projects, while we foster and nurture long-term, trusting, synergistic relationships with them for future developments.
Our Vision is to become the leading experts in clinical trials in Latin America due to our quality services, the guarantee of study subject protection, our reliability in providing outstanding results and establishing long-term trusting relationships with our Clients.
SERVICES
CLINICAL TRIAL SERVICES, PHASES I TO IV
Clinical Study Feasibilities
Fast and comprehensive feasibility evaluations for your clinical trials, covering multiple medical specialties and including Key Opinion Leaders (KOLs), experienced Principal Investigators and also new pre- qualified sites/ investigators.
Project Management and Strategic Planning
Our regulatory strategy, local expertise and management skills allow us to face challenging timelines and keep pace with expectations. We can be the leader CRO within a specific study or adapt and follow the leadership set by the Sponsor.
Regulatory Study Management
Includes initial MoH submissions, submission of protocol amendments, new sites/investigators, updated safety information, progress reports, final study reports, etc.
Most importantly, we carefully and responsibly manage written and face-to-face communications with MoH during the protocol evaluation process, keeping our Clients well informed about the interactions and outcomes.
Clinical Trial Monitoring
Includes Site Selection Visits, Site Initiation Visits, Routine Monitoring Visits and Site Closure Visits. We are able to operate under customized risk-based monitoring plans or plans provided by the Sponsor covering 100% SDV or reduced SDV.
We are rigorous and meticulous in the follow-up of issues at the clinical research sites, while providing enthusiastic support, training and surveillance throughout the study. Our senior staff and low-turnover allow for long-term, quality and committed interactions with site staff.
Safety and Pharmacovigilance
We are able to manage effectively safety data at the local, regional or global level both for investigational and marketed products.
Quality Assurance
We keep our processes and your projects under control through the implementation and oversight of our in-house, updated, precise Standard Operating Procedures (SOPs) or the Client’s SOPs if this is your preference.
Patient Recruitment and Retention Services
We develop specific recruitment and retention plans and materials in compliance with local laws and regulations, with focus on the disease of the study, the stage of the disease and the healthcare professionals involved. Although early start is recommended, we are able to implement rescue strategies with success too.
Vendor Evaluation, Qualification and Oversight
Our vendor evaluation and oversight process allows you to rest assured about the quality of outsourced imaging or laboratory services. Implementation is possible at the local or regional level, according to the protocol requirements, logistic challenges and Client´s preference.
Development of Study Documents
Our team is able to develop the study protocol, patient information sheets and informed consent forms, case report forms (CRFs), study manuals, drug labels, etc.
Data Management
We offer full range of data management services and systems, including amongst others, Oracle Clinical; Oracle Remote Data Capture (RDC) Onsite and Argus Safety. All of them are GCP/ICH and FDA compliant and have been fully validated.
Statistics
We provide sample size calculations, randomization schemes, statistical analysis plans (SAPs), statistic programming, graphs, tables, listings and statistical reports.
Medical Writing
Our medical team reviews and provides input during the protocol and informed consent form development process, as insight into the trial recruitment and retention plans. Specifically regarding medical writing, we can prepare final study reports for regulatory submission but also provide medical content articles, short reports or newsletters to communicate updates of the clinical trial or final study results to participants and key stakeholders.
BIOEQUIVALENCE STUDIES
We are able to perform the complete bioequivalence package comprising study and protocol design, regulatory submission, clinical phase and analytics or partial services at your convenience. Our bioequivalence studies are accepted in Argentina, Brazil, Chile and Perú.
PRODUCT REGISTRATION
We assess the opportunity of registration of your products in Latin America, and provide the know-how, regulatory and medical support needed to bring your product to the market.
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