Services
Our Services
Integrium has the experts, the expertise and the experience, to manage Phase 1 – 4 cardiovascular, metabolic disease and dermatology trials of all sizes across the world. We have an unparalleled track record in delivering well-executed study workscopes - from trial startup through to clinical trial reports.
Quality assurance comes into play at every level of our work process to ensure that each trial is conducted with only the highest levels of compliance and rigor. Our comprehensive Service Commitment reflects the seriousness with which we approach our work and is a guarantee of our dedication to both our research and to our clients.
So that we remain flexible and in tune with the needs of clients, Integrium offers each of our clinical trial services as part of a single, turnkey solution or on a stand-alone basis. Regardless of whether you use one of our services or the full spectrum, we will perform our services with the highest levels of customer service. Here are some of our service offerings:
- CV Core Lab
- Planning and Feasibility
- Study Design and Protocol Development
- Study Start-Up Services
- Project Management
- Site Monitoring
- Drug Safety and Medical Monitoring
- Data Management
- Biostatistics and Statistical Programming
- Medical Writing
- Consulting Services
- Patient Recruitment
Data Management
The discipline of data
Data management is essential in clinical development and it influences the quality of data received from investigative sites and of that delivered to the statistical and medical writing groups. So an interactive collaboration between data management and other disciplines of the clinical development process is needed. Integrium’s Data Managers possess up to 10 years of experience in the pharmaceutical and CRO industry and have worked on a wide range of projects both full service and stand alone, EDC or Paper-Based CRF projects.
Our meticulous attention to detail has resulted in a successful history of completing data management tasks on time and within budget. And it is this depth of experience that ensures we've got the processes and policies in place to effectively focus on high-quality results. Our data management specialists are actively involved and accessible from start to finish in order to ensure that the data captured support overall objectives and all necessary regulatory requirements.
Integrium's staff has worked on multiple EDC platforms including PhaseForward, PDS, DataLabs, DSG and ClinPlus Data Management in EDC mode in the past years. In 2009, Integrium locked all of their clinical EDC databases on time or before the projected Database Lock date.
Our data management services include:
- Case Report Form (CRF) design
- Database design
- Data management plans/guidelines
- CRF management
- Double data entry (when Paper CRFs are used)
- Data validation and review
- Medical coding (WHO, MedDRA®, etc.)
- Electronic data processing/reconciliation
- Data migration