IT compliance services address GMP, GLP, GCP, QSR, PDMA, HIPAA, SOX, GDPR, HR privacy, and other applicable regulations. We have a proven track record validating stand-alone, enterprise, and multisite systems used in regulatory compliance, clinical operations, laboratory data management, manufacturing/distribution operations, … see more

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, …

Assistance with regulatory submissions and compliance. Ensure compliance with international regulatory standards, such as CE marking for the European market. Prepare and maintain technical documentation, including Device Master Files (DMFs). … see more

Medical Device Software Development, specifically Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), involves the design, creation, testing, and maintenance of software that is intended for medical purposes but functions independently from any hardware medical device. This specialized service caters to the evolving needs of the healthcare industry by leveraging software solutions to diagnose, treat, or aid in patient care without being integrated into tangible medical equipment. … see more

• Decentralized trials

• Advise and support Clinical trial technology solutions (EDC, IVRS, eCOA, …).

• Assist in planning and conducting clinical trials to gather safety and efficacy data.

• Manage data collection, analysis, and reporting for clinical studies.

• Respond to questions regarding completion of CRFs, interpretation of data reports, etc.

• eCOA provisioning

• Vendor Qualification

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

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.