Created in 2009, founded by a group of highly qualified people with a vast experience in CROs and pharmaceutical companies, is a company with Spanish identity and international vocation.
is not only a CRO, but a Company giving an added value to customer in study design, clinical development planning and successful regulatory timelines to achieve customers milestones.
We are focused on our customer`s needs and their success, we adapt our team and resources to the customers needs and goals in local or international studies.
Most of our key employees have more than 20 years experience in Clinical Research field. is a dynamic team specialized in different fields which altogether provide a real and updated vision of clinical research world and new scientific developments.
offers to customers clinical research services to improve the quality of investigational products development optimizing the processes and activities of clinical research and market access.
delivers simplification of complex processes of clinical projects. We apply a full range of tools from field-tested technologies and with our experience and resources we are able to manage programs of any size in the most efficient way.
WHY CHOOSE US?
Our customers often need to outsource or just a partner that can develop and coordinate all the necessary activities required to perform clinical research. We facilitate, with the experience of our resources efficiently and efficacy, the development of clinical projects of any size and therapeutic areas. provides a full range of services from project design through to the publication of results, with expert project management to avoid and anticipate with contingency plans any possible deviation from the original project goals.
Successful implementation of these projects requires rapid site identification and study start-up, effective patient recruitment and achievement of end-study timelines. Our experience with the European regulatory process provides our clients the achievement of start-up milestones, thanks to our in-depth regulatory expertise, knowledge of sites and investigators. is composed of a complete team of experts who understand the local clinical requirements, the cultural and linguistic specifications and regulatory requirements to set-up the project with the strategic thinking in study design, clinical development planning and successful regulatory strategies, to choose the best option for the project. expert planning and project management will reduce the project risks by minimizing delays, and consequently the project cost, ensuring that the agreed deadlines are met with the highest quality.
- Improve customer project timelines, quality and cost.
- Business partnering: Create synergic solutions close to our customers to solve their challenges
- Strive to maximize development and improvement of the customer experience and outcomes:
- Short-term: Operational
- Medium-term: Tactical
- Long-term: Strategic
- Long-term customer retention.
- Compliance with legislation
- Compliance: GCPs, GPP, ISO14155:2020
- Highest quality (APICES SOPs and validated systems)
- Highest levels of data integrity and accuracy
- Achieving project timelines
- Outcome measurements
- Goals achievement
- Optimizing procedures to give an excellent time-quality-price ratio
has implemented a Quality Management System in compliance with the standard ISO 9001:2015 (certificate No. 9122.APCS), based on the Services Process Map which includes owner, inputs, resources, risks, controls and KPIs corresponding to each of the internal steps.
An extensive list of Standard Operating Procedures (SOPs) have been developed to cover the execution of the different services offered by , adapt to client SOPs as and when requested.
Procedures are designed to engage with the customer in the verification of all steps and outputs in order to obtain customer feedback before proceeding to the next step.
has implemented quality control activities to detect and register non conformities and to establish, implement, follow-up, document and evaluate corrective action plans, in order to assure compliance with clinical trial protocols, applicable regulations, applicable guidelines (e.g., GCP, GPP, ISO14155:2020), standard operating procedures and policies and actively seek quality process improvements.
Project specific risk assessment allow us to adapt quality control resources to a risk-based approach, according to customer needs and project complexity, adjusting the service cost and time with quality to fulfill customer requirements.
OUR MAIN CUSTOMERS
- Headquarters and Subsidiaries
- Local (Spain) or International: Europe/America
- Pharma Companies
- Medical devices Companies
- Biotech Companies
- Veterinary products Companies
- Cooperative Groups
- Public research organizations