Business & Project Managementqointa has experience with organized systems and with creative driven solutions. You get access to qointa's advisory group and leaders will help guide the creation of a successful project.
Business Strategyqointa supports companies by via focused project designs, specific timelines and project plans based on project requirements and external resources needed by the sponsors to complete a successful project.
Project Implementationqointa provides expert project implementation and management teams that are focused on organized systems in healthcare. Our experience includes database utilization, HIPAA compliance, structuring of resources, integrated operational processes and implementing various healthcare lifecycle systems like EDC, LIMS, CDMS, …( see also Cloud Based Clinical Trial Strategy and Development)
qointa has specialized in providing a broad range of solutions and services relevant to Electronic Data Integrity and Computerized Systems Compliance, including, but not limited to, the following:
- ICT/IT/IS Quality System and Audits
- Computer Systems Validation
- 21 CFR Part 11 Compliance
- Infrastructure Qualification
We offer a range of clinical and business related services from expert personnel - at a speed and quality that you've never experienced before.
Whether you need assistance, or even just another set of eyes and opinion, qointa delivers comprehensive concrete action plans in
- Clinical Operations
- Site & Department Audits
- Technology Implementation
- Site and Investigator Training
Clinical Datamanagement Support Services
Consulting services for strategic design of Late Phase Studies & Risk Management Programs
- eCOA provisioning
- Protocol development, CRF design
- Data Analysis Plan & Report development
- Study start-up activities
- Development of Study Reference Manuals & other study materials
- Investigator and Study Coordinator training
- Medical writing
- Clarify processes and logistical procedures
- Respond to questions regarding completion of CRFs, interpretation of data reports, etc.
- Vendor Qualification