Services
Clinical project management
(Inter)national study project management for small to medium sized clinical studies
Study start up
activities
EC submission, study document creation and administrative support
Investigator initiated research at academia
Support and consultancy for investigator initiated research at academia
CRA/Monitoring activities
All aspects of site management including on-site monitoring activities
Clinical Trial Systems Consulting
Support for implementation and/or upgrading systems supporting clinical trials
Workshops, training and coaching
Workshops, training and coaching for CRA & site personnel for companies and study sites
Clinical Project
Management
(Inter)national project management of clinical trials from start to finish, or individual parts. By building a team and setting clear responsibilities, timelines and budget remain within scope without compromising on quality.
- Keeping track of timelines budget and quality
- CRO / Vendor Management
- CRA Management
- Setting a risk based approach
- Incorporate a patient centricity mindset
- Use of online subject recruitment activities
Study start up
activities
Study start up and execution of all operational aspects, including submissions, development of study documentation, translations and administrative support
Development of study documentation
Writing and/or reviewing study-related documents including:
- Subject information and informed consent form
- Monitoring guidelines
- Study (laboratory) manuals
- Vendor management plans
- Datamanagement plans & eCRF guidelines
- General documents for clinical research like SOPs and training materials
Assisting with submissions
Preparation and submission of submission packages and amendments to Ethic Committees, Competent Authorities and hospitals to obtain approval.
Administrative support
Set up and maintenance of study files (TMF and ISF) for sponsor(s) and at clinical trial sites.
Translations & translation review
Translation of study documents/training materials from English to Dutch (and vice versa). A (medical) validation and content review of study documents previously translated.
Investigator
initiated
research
In recent years stricter regulations and requirements for the conduction of clinical investigator initiated research have been implemented in academia and at health care institutions. Academic study teams are often composed of healthcare- and/or research professionals whose primary objective is patient care. Without clinical research experience, valuable time and resources can be wasted in achieving the necessary standards in conducting clinical trials.
Does your clinical study team has questions like:
- How do I write a monitoring plan?
- How shall I set up a (e)CRF with associated edit checks?
- How do I set up, execute and inform my study team on corrective and preventive actions (CAPA)?
Is your study team in need of additional support like:
- Detailing study processes e.g. developing a SOP (Standard Operation Procedure)
- Trial management of multicenter studies or a consortium study / (co)Monitoring of study data
- Defining study critical data and processes and how to incorporate them in a monitoring plan
- Feedback from an experienced research professional helping you on your way
CRA/Monitoring
activities
CRA/Monitoring activities include performing selection-, initiation-, monitoring- and close-out visits for clinical studies, contract negotiations with study sites and all other activities that are needed to run a study successfully at a site. Depending on the scope these activities can be performed on-site and/or remotely on paper or eCRF. Monitoring is possible in hospitals in The Netherlands and the Dutch speaking part of Belgium.
Clinical Trial
Systems
Consulting
Nowadays clinical trials are supported with a range of software applications to collect, transfer, analyse and store obtained subject data and study results. Also in clinical operations systems are being implemented to keep track on study progress and KPIs or the tracking&tracing of derived subjects material (labsamples/MRI).
New technologies and new systems will lead to new ways of working. Software implementation is a lengthy process, in which day to day business continues while learning, training and managing the new system can become a hurdle accepting a new way of working.
Is your team in need of additional support with the implementation of a new software system or a planned upgrade?
- Collection of system requirements from all parties and the preparation of a requirements list fitting the needs of the organization
- SOP revision following system upgrade and/or new requirements
- Help with verbal/written translations of IT terminology into Clinical terminology (and vice versa)
- Review of system specs looking from an operational perspective
- Software testing prior to launch
- Implementation by developing training materials and other supportive documentation
- System support beyond implementation
Workshops & Training
Workshop and training for CRA & site personnel for companies and study sites on amongst others: basic GCP (Good Clinical Practice), monitoring, Risk based monitoring, CAPA reporting
Coaching junior CRAs and CTAs
On-the-job guidance of junior CRAs and CTAs
Looking forward meeting you and helping you find your solution.
Hope to see you soon!
- jolanda.schavemaker@jsclinical.nl
- +31 (0)6 1109 3209
