Our experience with European regulations give us the opportunity to meet the start-up deadlines. has comprehensive and detailed own Standard Operating Procedures (APICES SOP) to guide and train all the staff, to ensure operations are carried out in compliance with industry standards, ICH-GCP, GPP or ISO 14155:2020 guidelines, as applicable & local regulations and to fulfill sponsor requests and requirements.
A Project Manager (PM) is asigned for each project who ask as an unique contact point for the customer. The PM is deeply involved in the project and remains close to the customer to perfectly know their expectations at every moment of the project. A good project planning prior to start any study activity will let our customer save time and money in order to prevent any project deviation and establish the appropriate contingency plan.
A Project Management Plan is completed including agreements related with vendor’s management, communication plan, quality control activities, human resources, project timing and milestones and applicable SOPs.