What can we do for you?
When the timing of milestones, such as a database go-live or a database lock, becomes critical, we provide immediate on-demand data management services which will facilitate your clinical workload and help you in reaching your challenging timelines.
Our offer
We offer highly flexible hands-on data management services for any stage of clinical projects from study start up to database lock. We customise our approach, focussing on your particular needs to support on-time delivery of your projects, with high-quality data, tailored to your specific study requirements.
Our strength
We are "firefighters", uniquely combining a high level of expertise and experience with immediate availability, flexibility, and fast delivery. We do not offer start-to-end project data management.
Offered services
Review and query management
We offer review and query management of clinical trial data. We can review data line listings or any other format of listings provided by the client, according to the Data Management Plan. If requested, queries can be entered directly into the EDC system.
User Acceptance testing
User acceptance testing (UAT) of eCRF and of edit checks can be performed. We will test if the eCRF holds all required elements as described in the protocol, and if performance of the eCRF is as expected. All edit check types (e.g. electronic or manual edit checks) can be tested according to guidance provided by the client.
AE & SAE reconciliation
Adverse events, adverse drugs reactions, and serious adverse events review and reconciliation is an essential part of data management for clinical studies. We can perform this review and reconcile AEs, ADRS, and SAEs with medical history, concomitant therapy, and the clients' central SAE database.
Coding
Coding of medical terminologies (adverse events/medical history/medications) to ensure medical logic and consistency can be performed on the clients' coding system. We have experience with MedDRA and WHO dictionaries.
Please contact us for more information
Use our contact form to get in touch with us today and learn more about how we can help you. Alternatively, you can also send your email directly to info@molhuizen-cdm.com
Location
Annette Molhuizen CDM Services
Nieuwkuijk, Nederland
info@molhuizen-cdm.com
About us
Annette Molhuizen has more than 25 years of experience, working in various roles in the pharmaceutical industry, CROs, and in clinical settings. She holds specialized data management knowledge in diverse fields such as neuroscience, oncology, and dermatology, with a focus on phase III and IV/post marketing trials.
After more than 20 years working as Lead Clinical Datamanager for Johnson & Johnson Innovative Medicine, she is now employed as Advisor Research Data Management for Máxima Medical Center in The Netherlands.
