Trial Execution Technology

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

VEEVA VAULT CLINICAL SUITE combines Study-start- up, eTMF and a CTMS (Clinical Trial Management System) built on a single Veeva Vault Platform which 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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A unique clinical research center in Europe with its own operating room

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Trial Execution Technology