We add value to customer in study design, clinical development planning and successful regulatory timelines to achieve customers milestones.
APICES 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.
Delivering simplification of complex processes of clinical trials. We apply a full range of tools like field-tested technologies and with our experience and resources we are able to manage clinical trials of any size in the most efficient way.
Successful implementation of these projects requires rapid sites 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.
APICES team’ of experts, 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. Our 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.
A company with a clear and exclusive differentiation:
> Adaptable and Flexible.
> Local Expertise and Global Reach
> Personalized Service
> Experience in a wide variety of Therapeutic Areas
> Stable and Experienced Staff (low turnover rate)
> Adept with the Latest Technology Solutions
Our objectives
Our quality
An extensive list of Standard Operating Procedures (SOPs) has 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.
We implement quality control activities to detect and register nonconformities 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 fulfil customer requirements.