Aml Research

What we do

AML Clinical Services provides focused clinical research services to pharmaceutical, medical device and biotechnology companies, contract research organisations (CROs) and research sites.

 A dedicated team of qualified research professionals is available to assist in any stage of the conduct of  clinical trials, in any therapeutic area.  We have experience in pre-marketing as well as late phase and post-marketing trials.

AML retains a small-scaled organization to guarantee close oversight, commitment, loyalty and low turnover. Our employees are valued for their high experience, knowledge, flexibility and dedication to their responsibilities.

Contact

Tempelzicht 8

3210 Linden, Belgium

+32(0)16 78 21 70

info@aml-research.be

connect with us

Mission statement

It is our mission to make each and every clinical trial a success by reducing study start-up time, meeting project timelines and assuring high quality clinical data.

With our CAN DO attitude we turn problems into challenges to manage.  And while doing this, we value team work as well as integrity, open communication and mutual respect.

In the picture: 2020 - Year of Changes

The way clinical trials and investigations will be conducted in the European Union (EU) will undergo major changes in 2020.  Both trials with investigational medicinal products as investigations with devices are facing the implementation of new EU regulations.

The Clinical Trial Regulation EU No. 536/2014 entered into force on 16 June 2014;  the timing of its application depends on the development of a fully functional EU clinical trials portal and database. The Regulation becomes applicable six months after the European Commission publishes a notice of this confirmation. The entry into application of the Regulation is currently estimated to occur in 2020.

The Regulation will ensure a greater level of harmonisation of the rules for conducting clinical trials throughout the EU. It introduces an authorisation procedure based on a single submission via a single EU portal, an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, and transparency requirements.

It will also make it easier for pharmaceutical companies to conduct multinational clinical trials, which should increase the number of studies conducted within the EU

 

On 5 April 2017, the EU Regulation on Medical Devices No. 2017/745 was adopted. This regulation  entered into force on 25 May 2017 and will progressively replace the existing directives. The new regulation will be fully applicable in May 2020 and establishes a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety. This in turn will boost confidence in our medical devices industry.

At AML we are ready to embrase the changes and face the challenges these new regulations will bring in our daily work.