Global trial and site management

Whether you intend to conduct a single-country single-site or an international multi-centre study, we can take responsibility for every aspect of it.

Clinical Project Management

A team of clinical trial experts dedicated to your trial, supported by modern, user-friendly and secure technology, will ensure that all stakeholders are kept up-to-date with any relevant event in a transparent and timely fashion.

Your dedicated Project Manager acts as liaison between clinical operations, administration and logistics and coordinates all participants and activities

They centralize and harmonize all the relevant information so that you can easily access and analyse it in real time.

Your Project Manager remains your main contact for the entire duration of all the contracted services.

CTMS

As well as receiving frequent updates from your Project Manager, you can keep a close eye on the progress of your trial through our Clinical Trial Management System.

Click here to download our CTMS factsheet

Investigational sites management

Find the right site and the right patient

Since we also run hundreds of trials at our own clinical trials unit, we are cognizant of the potential pitfalls that investigators might encounter, which enables us to anticipate all necessary preventive actions.

Having directed all types of single and multi-centre international trials in a broad variety of therapeutic areas, we have qualified some of the world’s most competent specialised medical centres, KOLs (Key Opinion Leaders) and patient associations.

We build longstanding and solid relations with site staff and develop a deep understanding of the challenges we face in order to minimize risk.

Some of the parameters we assess prior to qualifying an investigational site are:

Site administration and operational support

We can also manage all the relevant admin, logistics and general site support operations on your behalf, so that you can focus on the actual progress of the study.

From the inception of the project through to its close-out, each investigational site benefits from a dedicated team and support line enabling immediate assistance from the relevant administrative and technical staff involved in the study.

Monitoring and Vigilance

Thorough medical oversight: the only road to safety.

From protocol development and study design through to study close-out, medical oversight of all stages and activities of your clinical trial is of prime importance to meet your objectives while ensuring the integrity of your data.

You are likely to require assistance in order to:

Compliance, compliance and more compliance to mitigate risk

We are highly conscious of the importance of demonstrating your commitment to patient safety to the regulatory authorities.

In order to authenticate the therapeutic potential of your product, you require fully compliant and high-quality bespoke vigilance and safety solutions so that you can comply with the strictest regulatory legislation, manage the risk-benefit-profile of your product and guarantee patient safety.

Dedicated Clinical Research Associates (CRAs)

Our in-house team of CRAs receive continuous training to ensure they remain knowledgeable and up-to-date about the latest techniques, technologies and changes in legislation. 

A Lead-CRA dedicated to your study directs a team of field-based CRAs and oversees all monitoring activities taking place at the participating investigational centres.

Risk-based monitoring plan

We carefully design a risk-based monitoring plan, which will serve as the guideline for all monitoring activities.

We focus on detecting, mitigating and preventing errors that might lead to risk in order to improve patient safety and enhance the congruence of your clinical data.

A patient-centric and proactive early detection approach minimizes risk and enables effective and efficient solutions.

Remote monitoring

When appropriate, we utilize virtual monitoring technology so that CRAs can perform monitoring functions remotely, which reduces the significant expense and downtime caused by travelling

Keep on top of vigilance regulatory updates to avoid extra costs and delays

Strict compliance with vigilance procedures (ICH Good Clinical Practices) minimizes unnecessary extra expenses and delays.

Our team of vigilance-specialized professionals, composed of physicians, pharmacists and life sciences professionals, works closely with sponsors, investigators and regulators in order to effectively monitor, asses and report your safety data in a time-sensitive and regulatory-compliant manner.

Our  capabilities include: