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 brings a blend of structured systems expertise and innovative market-driven solutions. By engaging with qointa, you gain access to our advisory group and leaders who will play a pivotal role in steering the creation of a successful project.

Business Strategy
qointa aids companies by formulating targeted project designs, specific timelines, and project plans tailored to project requirements. We leverage external resources essential for sponsors to achieve project success.

Project Implementation
qointa furnishes accomplished project implementation and management teams specialized in healthcare systems. Our proficiencies span database utilization, HIPAA compliance, resource structuring, streamlined operational processes, and the execution of diverse healthcare lifecycle systems such as EDC, LIMS, CDMS, and more ( refer to Cloud Based Clinical Trial Strategy and Development)

Whether you require support, a fresh perspective, or simply an additional viewpoint, qointa offers detailed and actionable plans. Feel free to inquire for further information, and we could potentially provide valuable assistance.