Study
Conduct
You can delegate anything from study start-up to site close-out to us. Whether you require a single service or want to entrust us with a complex project, we are ready to hit the ground running!
Fields of Expertise at Ad Hoc Clinical include drug studies from Phase I to IV, PASS and PAES projects, Managed Access Programs, ATMPs, pre and post CE label device research, IVD performance evaluations and non-interventional studies.
Our Approach combines strong international experience with local know-how, providing personalised guidance throughout every stage of your research and ensuring consistent quality through our ICH GCP compliant SOPs.
Key Advantages for our clients include fixed fees through the use of Ad Hoc Clinical’s SOPs, full management and quality control by our team and the ability for you to maintain oversight without day-to-day operational burden.a
STUDY STARTUP
This covers all types of activities to enable the actual start of a study, including:
-
Feasibility studies and site selection
-
Development, customization and translation/validation of study documents (e.g. Informed Consent Form, Patient’s Diary, Emergency Card, IMP label)
-
Ethics and Competent Authority submissions
-
Privacy Committee submissions
-
Site contract and budget negotiations
-
Preparation of the Investigator files and Trial Master File
As study start-up is a critical step in the clinical trial world, it often goes hand-in-hand with challenging deadlines. At Ad Hoc Clinical, we believe that involving the same team in each step of the way (and especially for submissions), significantly improves efficiency, shortens start-up timelines and reduces costs. Moreover, it allows to build positive professional relationships with the study sites and regulatory bodies from the very beginning.
SITE MANAGEMENT AND MONITORING
With a unique location in Europe and Belgium, we have access to the best-in-field CRAs, key-opinion-leaders and promising peripheral sites. Moreover, our formula of combining office-based and home-based CRAs significantly increases flexibility, reduces travel costs and improves work efficiency.
-
Site qualification visits
-
Site initiation visits
-
On site data abstraction (on site CRF completion)
-
Remote and/or on-site monitoring
-
Unblinded pharmacy monitoring (if required)
-
Ongoing site management
-
Site close-out visits
PROJECT MANAGEMENT
After having defined the critical success factors (e.g. scope of work, timelines, roles and responsibilities, involvement of third party vendors, applicable SOPs, training, communication, deliverables,…) with the client through a Services Agreement, the Ad Hoc Clinical Project Manager will be responsible for the coordination and oversight of each operational component of a project from A to Z.
He/she will:
-
Ensure each project team member is adequately trained
-
Serve as a link between the Sponsor and project-team members
-
Supervise the project team
-
Coordinate and track all project-related activities
-
Ensure compliance with project timelines and budget
-
Communicate trial progress and milestones to key stakeholders
THIRD PARTY SELECTION
e.g. data management service provider, central laboratory...
Discover our other services
