Project management solutions in Belgium

When we lead your project, our main concern is to release you from any stress related to the project management. We initiate and manage the project team for your trial, and we coordinate communication between all parties. What your dedicated project team will do for you:

• plan and execute critical milestones for each study;

• provide excellent customer service and proactive communication;

• coordinate communication between all parties including investigators, committee members, and sponsors;

• oversee day-to-day activities of all team members;

• identify efficiencies and processes to improve your data quality.

Every clinical trial should have an efficient safety program and appropriate level of protection for the study subjects. MD Trials has a transparent and reliable approach to safety data and a sturdy quality system. We can offer you a comprehensive Safety Management Plan, tailored to your product.

Our Medical team is official registered as European quality person for pharmacovigilance (EU QP PV).

Every aspect of the study must be documented in order to obtain useful data and demonstrate compliance with Good Clinical Practice (GCP) guidelines and with all applicable regulations.

Our Clinical Trial Documentation services help sponsors generate documents which meet (local) requirements and applicable guidelines.

Choosing the right site is not an easy task. Yet, it is key to choose well, to avoid the need for a new site or replacement site during your trial. 

Our dedicated team assists you in finding the sites with the right requirements for your specific needs. Our relational network with sites worldwide ensures appropriate and quick selection, based on the requested patient volume, equipment and investigator’s expertise.

MD Trials supports sponsors and investigators by identifying the stakeholders that need to be involved in the application reviewing process, such as EC's, IRB's, National Competent Authorities and FDA.

When it comes to monitoring, there’s no one-size-fits-all approach. Maybe your trial needs more than on-site monitoring? MD Trials can provide you with a tailor-made plan that fits your trial, including remote or risk-based monitoring.

Nowadays, the complexity of clinical trial procedures can make pure on-site monitoring expensive and inefficient. Therefore, MD Trials provides you with a custom monitoring plan that considers your unique study needs. In this, we provide options remote clinical data review, as a supplement to on-site monitoring. Our risk-based monitoring meets relevant regulatory body.

A critical aspect of our responsibility to our clients is to ensure compliance with the changing regulatory guidelines and requirements as well as adapting our services to the emerging trends in submission procedures and technologies. Regulatory support includes Serious Adverse Event (SAE) Reporting, compliant with all regulatory guidelines (FDA and European Regulatory Guidelines).

The CE marking is a key indicator of a product’s compliance with EU legislation and enables the free movement of products within the European Market. By affixing the CE marking on a product, a manufacturer is declaring conformity with all of the legal requirements to achieve CE marking and therefore ensuring validity for that product to be sold throughout the European Economic Area. This also applies to products made in third countries which are sold in the EEA.

We help you through the procedures for conformity assessment and help you to document evidence to support that your product complies in every way to the applicable EU directives.

Course Highlights

Historical and Global Regulatory Perspective, Ethics in Clinical Research, Good Science, Investigational Product Development, Team Roles & Responsibilities, Regulatory Document Management, Principles & Process of Informed Consent, Clinical Trial Preparation, Sponsor Visits, AE Analysis and Reporting and Practical Application of GCP-R2.

What is gained from this course?

This course provides an in-depth review of Good Clinical Practice (GCP-R2) and its practical applications in clinical trial management. The goal of this course is to provide training that will enable the participant to not only understand GCP-R2 but to feel confident that they know how to monitor and coordinate clinical trials.

Our dedicated team is specialized in the following therapeutic area’s:

• Oncology
• Cardiology
• Orthopedics
• Endocrinology
• Gastro-enterology
• Dermatology