- Project Management Plan
- Project Planning
- Recruitment Follow Up
- Trial Master File
- Site Staff Communications
- Investigational Product Management
- Payments management
- Sponsor Quick Comunication Tool (ACS)
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 14155:2011 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.
Project Manager develops a Project Planning to calendar the contracted activities to be agreed with the client prior to study start. PM monitors metrics on the internal processes and updates and gives feed-back of any deviation of the timelines established on each project and the reason of this deviation, if required.
establishes with the client the patient registration procedure prior to drug administration for randomized and non-randomized studies in order to get an appropriate control of study recruitment.
An Investigator meeting may also be organized to fulfill the customer Start-up study.
Our Clinical Operations team oversees patient recruitment and keeps the customer and coordinating investigators informed about any new patient recruited.
Recruitment strategies may also be performed, when requested, bearing in mind the high experience of in detecting and resolving recruitment issues.
Each study document is managed according to the guidelines and local regulations and following the agreed SOP and location with the customer.
A Clinical Trial Assistant (CTA) is in charge of preparation and update of the study file under de supervision of the CRA involved in the project.
Once the study is finalized, the Trial Master File is returned to the sponsor and a detailed report of documentation returned is provided for acknowledgement.
offers the customer the possibility to retain documentation throughout the agreed period.
establishes with the customer the frequency of telephonic contact/follow-up with the investigators.
Periodic reports with all contacts may be provided to the customers with the detail of relevant information discussed between parts.
agrees with the customer the necessity and the frequency of teleconference to review relevant issues along the project.
The Project Manager arranges every teleconference and provides the service for multi-conference with appropriate participating individuals. An agenda and the resulting teleconference minutes is provided to the appropriate people.
offers the following services to ensure proper management and accurate tracking of investigational products in clinical studies with the study sites:
- Selection of third party storage facility to provide shipping and storage services that meet the specifications provided by the client.
- Investigational product labelling design in agreement with the requirements of Annex 13 of the EU GMP.
- Coordinate Investigational Product distribution to the Investigational Sites.
- Stock maintenance both at the site and at sponsor facilities.
- Monitoring of Investigational Product at the Investigational Site.
- Return/Destruction of Investigational Product from Investigational Site
- Investigational Product reconciliations.
Including management of payments to hospital foundations, investigators, Ethics Committees, vendors and patients, when applicable.
Apices Customer Services (ACS) is a group of web-based electronic tools implemented to make easy the study management, including start-up tracking, patient recruitment, monitoring visits scheduling, investigational product management, or document sharing, amongst others .
Thus ACS is developed as a form to get better communications between all projects management members, investigators and sponsor who are involved in each study.