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.
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.
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.
We provide sample size calculations, randomization schemes, statistical analysis plans (SAPs), statistic programming, graphs, tables, listings and statistical reports.
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.
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.
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.