Focus on 'your' needs

As a privately owned and actively involved CRO, we are able to make your success our primary focus. We are not the large disconnected CRO that cycles people through trials. We care about your results. Clinitude provides you both with a dedicated clinical team and adaptive trial management solutions that you need to reach your goals and timelines.

Our Expertise and Services

CRA Liaison – what is this ?

Site Management, Site Monitoring and Remote Monitoring, Global Regulatory Submissions, Project Management, Feasibility and Site/Investigator Selection/Identification, Clinical Research Transformation Services.

Therapeutic Experience

Our primary experience lies in oncology, immuno-oncology and interventional oncology, neurology and medical device studies. Other therapeutic areas include: Pain, Gastroenterology, Dermatology, Nephrology, Infectious Diseases, Rheumatology and Cardiology studies.

CRA Liaison

Clinitude is introducing a new revolutionary way of site monitoring.

The last few years the buzz words in the clinical trial industry have been: Risk-Based Monitoring (RBM), targeted monitoring, remote monitoring, and how these innovations increase data quality and reduce costs.

But what exactly will RBM change? How will RBM affect the CRA and the traditional way of monitoring? And how can we adapt to these changes?

Our CRA Liaison service is a game-changing approach that combines the efficiency of targeted and remote data review with the effectiveness of CRAs and site relationships.

Let’s explore how RBM works in three important steps:

Quality by design

The first step is the design of the study.

When developing the study design, the main goal is to remove any unneeded procedures and minimize major operational risks. This is a patient-centered approach.

Planning and Setup

The second key step is the planning and setup of the study.

During this step, Key Risk Indicators (KRI) are assessed and a thorough risk mitigation plan is prepared.

In this stage, the critical data is identified and a dynamic source data verification (SDV) plan is drafted and set up. These key steps form the foundation of the RBM approach.

Execution of the study

The third step of the RBM approach is study execution.

A central team is organized and remote, target monitoring is started – instead of 100% SDV. It is this step that triggered us to develop the revolutionary CRA Liaison model. For many years our experience has been with ‘traditional’ monitoring, and in fact, the whole industry has been trained in a 100% SDV culture. Should we now expect that CRAs know how to handle RBM? What about the quality of site relationships, which can impact trial success? RBM provides oversight on the most important aspects of the trial and subject safety, but until now CRAs have been working with the data in an isolated way.

Our CRA Liaison model solves this problem because it integrates RBM with high quality site management and interaction with cross functional teams.

Role of the CRA Liaison

Ensures harmonization of in-house
monitoring practices.

Verifies compliance and quality of
the data.

Uses their visualizations to evaluate risks and to
trigger relevant activities.

Acts as liaison between central team
and on site CRA.

Ensures compliance with the procedures to
apply in the event of SAEs.

Initiates contact with different team members to
discuss findings and evaluations.

Adheres to protocol and regulatory requirements, ICH/GCP and standard operating procedures.

Performs remote review of all data to find trends and to verify if sites are well performing.

Remote review of all essential documents required at beginning, during and at end of a clinical study.

CRA Liaison - The feedback

CRA Liaison

Don’t settle for ordinary. Choose extraordinary.
It’s always a choice.

US office

Chicago

10 South West Loop, Riverside Plaza
Suite 875, Chicago, Illinois, 60606
United States
Tel.: +1 312 474 6080
Fax: +1 312 474 6099

Europe office

Belgium (HQ)

Alfons Smetsplein 3H1
3000 Leuven
Belgium
Tel.: +32 (0) 16 58 12 84
Fax: +32 (0) 16 46 55 52

Asia offices

Singapore

8 Marina View, #07-04
Asia Square, Tower 1
Singapore, 018960
Tel.: +65 (0) 6407 1163
Fax: +65 (0) 6407 1001

The Philippines

Cebu Ayala Business Park IT Tower 1
14B, Arch Reyes Str. & Bohol Ave.
6000 Cebu City, The Philippines
Tel.: +63 (0) 32 415 54 47
Fax: +63 (0) 32 415 54 47