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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management CAPA Management Audit Management Product Development

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Accelerate development with integrated design control and risk software.

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Featured Capabilities:

Design Controls Risk Management Risk Intelligence

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Streamline and manage all your data across all clinical investigations.

Combine Greenlight Guru Clinical with CTMS and eTMF

Combine Greenlight Guru Clinical with CTMS and eTMF for Clinical Investigations from BSI to streamline and manage all your data across all clinical investigations.

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ctms

Clinical Trial Management System (CTMS)

BSI CTMS is the backbone of your future clinical trial management. Plan, track and monitor all your pre- and post-market studies with complete oversight of all study relevant data in one system due to the seamless integration with Greenlight Guru Clinical. 

  • Study design and study setup based on templates
  • Local, regional and global studies
  • Site and principal investigator (PI) data base
  • Study and site budgets
  • Milestones and activities
  • Risk based site monitoring
  • Offline monitoring
  • Tracking of risks, issues, protocol deviations and (SAEs)
  • Risk based site contract and invoice tracking
  • Tracking of complete study communication (e-mail, phone, calls, letters...)
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etmf

Electronic Trial Master File (eTMF)

BSI eTMF delivers comprehensive functionality for all aspects of trial master file management for your clinical trials from study startup, to execution, flexible reporting and closing.

Full support of your own TMF structure or the TMF Reference Model from DIA with controlled access for all study partners e.g. sponsors, CRO and sites. Setup document plans and track the creation, reviewing and approval process with enhanced alerting functions. Perform regular quality control of all study documents. 

  • TMF reference model from DIA
  • Document plans with automatic creation of placeholders
  • Work on, upload, link, and save documents and e-mails
  • Review and approval workflows including electronic signatures
  • Document deadlines with alerting functions
  • Download complete eTMF with optional PDF/A conversion
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Customize Greenlight Guru Clinical to Your Needs

Get a demo of our EDC software and learn how you can customize your study to collect data more efficiently.

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500 +

MedTech Clinical Trials

Study Setup in 2-3

Weeks

Support for 40 +

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