Data Management
Our experienced team provides high quality clinical trial data management at every stage of your project. We offer a range of solutions from full-service to FSP, and are committed to supporting every client's unique needs from beginning to end. Intego Clinical is an expert on international data reporting requirements with strong in-house QC measures, and our clinical data managers are some of the best trained in the industry.
Meet our data management team
The success of your clinical studies depend on reliable, professional data management. Intego Clinical supports pharma, CROs and biotech through a flexible business model tailored to each company's specific needs. In an outsourcing industry characterised by high turnover, we succeed in sustaining long-term relationships with our clients and employees alike.
Intego's highly educated data management team understands your regulatory requirements and will support you at every step of the data acquisition process. We strictly adhere to ICH, GCP, and FDA 21 CFR Part 11 regulations as well as client-defined SOPs. We utilize a wide range of software solutions and EDCs to meet your particular study goals.
Professional Development and Continuous Education is a key focus of our organization. All employees receive ongoing mentoring from senior team members, monthly presentations from industry experts on hot topics, and other training programs to keep our team ahead of the curve to continue serving our clients at the highest standard. It is our continued investment in professional development and on-the-job training that has made Intego Clinical a leading provider of outsourced clinical data management with delivery centers strategically located in Eastern Europe and the United States.
Clinical data management training program
Our new training program targets healthcare professionals with strong fundamental knowledge in medical and pharmaceutical space. This course is designed to familiarize students with specific aspects of clinical data management work. We provide a comprehensive study of the best practices in clinical data management to assist individuals in developing a successful career in the industry. Participants will study, analyze, and discuss the full lifecycle of CDM processes, from protocol review and study design, to the required data elements and final steps of the clinical study completion.
Our data management services:
- eCRF design from ground-up, SDTM/CDASH annotation
- Creation of eCRF libraries
- Data cleaning and reconciliation
- Medical Coding implementation
- ePRO setup and configuration
- CDISC data standards
- SAE Reconciliation, Pharmacovigilance and Medical review
- Database build and validation of data entry
- Extensive data validation process
- Clinical team and site training
- Continual Quality Control review including audit trail logging
