Clinical Data Management

FSP for Clinical Data Management

When it comes to data management, do you select a more economical solution or a strategically-driven one? What if you no longer had to choose?

Combining the flexibility of our evolved Functional Service Provision (FSP) model with 25 years of global clinical experience, we provide you cost-effective results, strengthened by deep clinical and medical expertise across a range of therapeutic areas, innovative technology, and best practice data management processes. 

Minimise costs. Maximise quality.

Focus on your core competencies as our experts ensure the delivery of high quality data through our cost-efficient FSP approach. Our Functional Solutions can include customer or CRO SOPs, EDC (and other) systems, on and off shore resourcing solutions and all aspects of a CRO infrastructure. We provide rigorous implementation and adherence to a set of agreed-upon standards, so you can obtain results that align seamlessly with your research needs. 

  • 30%reduction in portfolio costs

Reduce timelines. Increase productivity.

ICON’s Clinical Data Management FSP solution, provides more than just expedited delivery. By using proven processes, such as in-stream validation and continuous data cleaning, we provide real time access to post processed datasets, and analysis dataset feeds on an automated  schedule. We generate fit-for-purpose results while minimising time-to-market.     

  • 50%more efficient
  • 6 weeksfrom protocol agreement to database go live
  • 5 daysfrom Last Patient Last Visit to database lock

Work with experts who know the industry.

Experienced project managers and indication-specific consultants comprise a team of collaborators that you can truly count on—for anything from rapid turnaround to strategic guidance in your therapeutic area of interest.

  • 10+Average years of experience per data management project manager

Transform productivity with proven technological support.

Proficient programmers

Seasoned programmers are the key to seamless data delivery. In addition to possessing industry certifications from SAS-developed training classes, members of our coding team have between 10-15 average years of experience.  

ICONIK Informatics Hub.

Enhance clinical data analysis with the help of ICONIK Informatics Hub, our powerful proprietary technology platform. It simplifies risk-based monitoring while complying with 2016 ICH GCP (R2) revisions.

ICON's Value Add

The model deployed by ICON was based around a dual focus of building a solution that would provide long term, continued service delivery improvements and cost efficiencies, while also managing the short term requirement to protect the portfolio and retain critical experience. ICON partnered with the client to ensure that goals were understood across the study teams and that an effective change management plan was put in place to de-risk the transition process. Once the transition was complete, we combined our expertise with that of our client partner to drive system, process and technology changes that enabled more long term improvements.

Case Study

  • The ChallengeICON was contacted by a mid sized pharmaceutical company looking for strategic Data Management support in Europe and Asia Pacific. The requirement was to transfer Data Management support from in-house resources to an external resource pool while maintaining experience and geographic capability. The transfer process was to be completed with zero interruption to an in-flight portfolio of more than 60 studies. There were clearly defined targets to improve delivery across a range of defined KPI’s over a three year term
  • The SolutionICON co-located resources next to key client hubs in Madrid, Sydney and Tokyo, whilst client staff transfers were facilitated in each location. As programmes within the portfolio transitioned to ICON, key client staff were provided the opportunity and encouragement to transfer from client to ICON. Additional back-up staff were made available from within ICON, and a change management plan was deployed to ensure continuity of portfolio delivery as the key priority during the transition period. A long term process improvement plan was implemented to drive KPI improvement over the term of the engagement
  • The Outcome100 staff deployed to the portfolio within the first three months, 40% of which were transferred from client to ICON. All study milestones and deliverables were met on time no disruption to the portfolio during the transfer process. >90% retention of transferred staff during the initial 3 year engagement. 50% reduction in database build cycle time over three years. 70% reduction in database lock cycle time over three years. Engagement renewed and continues seven years on. We transitioned significant elements of portfolio delivery to India