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Services for clinical & research organizations

Focus on Adoption

Invest in digital health solutions that fill clinical gaps and enable precision medicine. If you are a provider in search of the best tech to use in your study or clinical program, a research organization innovating ways to fill clinical gaps or you have an organization-wide digital health mandate, BML can help you find the best tech, secure the right tech partners, and run digital health clinical trials efficiently and effectively.

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Science and Tech

Get it right. Make sure you are using the best tech out there, efficiently and confidently.

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Science and Tech
services include:

  • Technology evaluations / device usage consultation

  • Algorithm development

  • Point-of-care technology integration and management

  • Application design and product/market fit

  • Technology customization

  • Technology partner connection and relationship management

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Clinical Integration

Have it matter. Leverage existing technology or develop new solutions to fill clinical gaps.

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Clinical Integration
services include:

  • Pilot testing

  • Long-term and in-home monitoring solutions (Sleep, ECG, respiration, BP, others)

  • Investigational testing and clinical trial management

  • Digital therapeutics (DTx)

  • Project management

  • Biometrics and digital endpoints for drug efficacy trials

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Regulatory Compliance

Do not compromise. Ensure your digital health solution is compliant for its intended use.

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Medical Device
compliance include

  • HIPAA and PIPEDA compliance

  • Support for medical device compliance in the US, Canada, Europe and all over the world.

  • Clearance for preliminary clinical validation or investigational testing (US IDE, Canada ITA)

  • Regulatory portfolio management

Medical Device compliance includes ISO 13485 Medical Device Quality Management, FDA 21 CFR 820, CE MDD (93/42/EEC) and MDR (2017/745), Health Canada MDR, Australia TGA and Chinese cFDA, including MDSAP audit, ISO 14971 Risk Assessment, IEC 60601-1 Safety and Essential Performance, ISO62304 Software Lifecycle Management, ISO 10933 Biological Evaluation of Medical Devices and ISO 62366 Human Factors / Usability Engineering;