qointa has specialized in providing a broad range of solutions and services relevant to Medical Device Development, including, but not limited to, the following:

• Software Development

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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
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Our compliance services include Strategic Compliance services, Tactical services, Service Level Agreement (SLA) based CSV services, and CAPA services. Our extensive experience with IT compliance covers areas governed by US FDA, equivalent international agencies, and other regulatory agencies. Our IT compliance services address GMP, GLP, GCP, QSR, PDMA, HIPAA, SOX, HR privacy, and other applicable regulations. We have a proven track record validating stand-alone, enterprise, and multi site systems used in:

• regulatory compliance
• clinical operations
• laboratory data management
• manufacturing/distribution operations
• sales and marketing

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We offer a range of patient-centric services that seamlessly integrate with your healthcare or clinical trial setting.

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• 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

qointa has experience with organized systems and with creative, market driven solutions. You get access to qointa's advisory group and leaders will help guide the creation of a successful project.

Business Strategy
qointa 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 Implementation
qointa provides expert project implementation and management teams that are focused on organized systems of 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)

Whether you need assistance, or even just another set of eyes and opinion, qointa delivers comprehensive concrete action plans. Ask us for more details and we might be able to help.