Our clinical project management team will effectively and efficiently manage clinical programs, focusing on quality and dedication to patients.
project managers have experience in clinical trial management and are highly committed to every procedure, bearing in mind timelines and budget.
It is a priority for our team to succeed in every clinical project providing overall guidance and leadership, and making sure the trial is successful, understanding that quality is of the utmost importance for any project.
Project Management Plan
Our experience with European regulations gives us the opportunity to meet the start-up deadlines. APICES 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 fulfil sponsor requests and requirements.
A Project Manager (PM) is assigned for each project who act as a 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 Planning
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.
Recruitment Follow Up
APICES 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 fulfil the agreed customer Start-up study timelines.
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 APICES in detecting and resolving recruitment issues.
Trial Master File
A Clinical Trial Assistant (CTA) is in charge of preparation and update of the study file under de supervision of the PM involved in the project.
For each study we can use paper TMF or eTMF, according to the sponsor’s instructions.
Once the study is finalized, the Trial Master File is returned to the sponsor, if eTMF was not used, and a detailed report of documentation returned is provided for acknowledgement.
If eTMF was not used, APICES offers the customer the possibility of sending the documentation to a specialized company for archiving during the period established by the regulation in force at any given time.
Site Staff Communications
APICES 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.
APICES 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.
And also…
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 internal communication between APICES study team members who are involved in each study.
