ITREAS understands the value chain and the need for more creative yet sophisticated outsourcing approaches that are required as a result of the increased cost of clinical development and higher demands for quality.

Timely planning and commitment, a practical but thorough qualification process, as well as a strong governance model are all key when pursuing outsourcing of tasks and activities.

Whether you are an investigator in need of operational support to translate your science into research, or whether you are a (bio)pharmaceutical company or CRO seeking partners to successfully design, execute and analyse your clinical trials, ITREAS can assist you to increase the quality of your research and services, whilst reducing overall study costs.

Our services range from an “all-in” concept to individual deliverables, such as:

• From concept to “submit-ready” protocol
• Preparation of documentation for submission
• Q&A with MOH, ethics committees

Start-up services and Study Logistics
• Feasibility & site selection
• Investigator training
• Patient information materials

Site Management
• Recruitment and retention
• Data quality

Endpoint Adjudication
• Collection & processing of core (efficacy & safety) datasets
• Blinded adjudication

ITREAS provides services to enable independent blinded adjudication of clinical events for large spectrum clinical trials, ranging from small scale to trials with thousands of events.

Our adjudication experts are experienced practising physicians specialized in radiology, cardiology, neurology, oncology, hepatology and nephrology. All members have served on multiple adjudication committees that performed assessments for both registration and non-registration clinical trials.

We provide extensive adjudication committee management and coordination services to ensure top quality data, an efficient workflow process and on-going quality control. We continuously monitor for available events for reviewing. This ensures short turn-around times, allowing Safety Boards and Endpoint Committees to monitor the core datasets continuously. Our coordination services additionally ensure on-going reconciliation efforts and timely resolution of queries and discrepancies.

Study Governance
• Steering / Executive Committee
• Safety Board (DSMB)
• Medical Monitoring - detection analyses of core safety parameters

24/7 Investigator support
• Randomization
• Protocol related questions
• Medical management of patients

Research Network Services
• Due to our participations in many clinical trials we have a significant number of quality clinical sites “available”.
• We also have many cross-links to other established clinical trial networks.