Trial Execution Technology

Trial Execution Technology

BK offers conduct of the clinical research services via state-of-the-art technology solutions selected carefully to ensure the highest quality of the clinical processes combined with relevant and adjusted level of customization. Clinical systems are licensed from leading technology providers – BK qualified vendors and solution partners, ensuring best in class technology solutions for our clients.

VEEVA VAULT CLINICAL SUITE combines Study-start- up, eTMF and CTMS (Clinical Trial Management System) built on a single Veeva Vault Platform that meets all rigorous usability, scalability, performance, validation and security requirements of the life sciences industry.

  • A single source of data – one source of clinical data and documentation for the sponsor, CRO and other partners.
  • Improves visibility, control, global alignment – enables complete oversight of the end-to-end clinical process in real-time.
  • Comprehensive compliance: enables higher quality of trial execution, tracks all data and documentation flows, compliant with regulatory requirements and best practices, always ensures inspection readiness.

CLINCASE E-CLINICAL TECHNOLOGY delivers end-to-end EDC and clinical data management (CDM) system on a unified platform ensuring highly customizable and simple-to-use, straightforward functionalities.

  • Extensive, customizable reporting capabilities and dashboards.
  • Randomization – integrated, web-based randomization inside the eCRF, delivers easy-to-start, easy-to-manage online randomization.
  • Encoding – encodes verbatim text entered into the eCRF with use of industry standard dictionaries (MedDRA, WHO-DD).
  • SAE reporting – enhanced functionality for SAE reporting via EDC with email notifications.
  • Medication inventory – organizes the drug shipment process, support for the central and local logistics.
  • ePRO – flexible set-up and maintenance of system with user-friendly design of electronic questionnaires

ORACLE ARGUS SAFETY is a comprehensive adverse event (AE) management platform, it is the market-leading solution for processing, analyzing, and reporting adverse event cases originating in pre- and post-market drugs, biologics, vaccines, devices, and combination products.

  • Single global database for efficient case processing via automations and ease of use.
  • Lower cost and complexity through SaaS deployment.
  • Flexible licensing models enabling organizations to grow with Oracle Argus.

Effective study implementation through a unique object-orientated approach and metadata structure. Full control over data import and export formats, simplified process of exporting data for statistical analysis.

DOCUSIGN delivers the most trusted and widely used e-signature solution to accelerate finalization/approval of documents with status/progress tracking in real- time. DocuSign eSignature complies with the U.S. ESIGN Act, HIPAA and UETA, EU eIDAS regulation as well as the e-signature practices set forth in EMA/ICH guidelines and FDA 21 CFR Part 11 with tailored functionality and packaged service offerings.

  • Limitation of paper and manual processes ensuring time savings and cost reduction.
  • Global availability, enhanced security, compliance and auditability .

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Data Management

A unique clinical research center in Europe with its own operating room