Data and compliance challenges in clinical research
Clinical research monitors and measures the efficacy, safety and benefits of treatments and interventions offered to patients to prevent, diagnose, and manage diseases. The goal is to improve clinical outcomes for patients. Clinical researchers are generating and analysing increasing volumes of data to better understand and diagnose diseases. Your decision-making relies on the accuracy and traceability of that data and the consistency of your lab processes generating and using that data.
Clinical research labs deliver varied and complex services; from managing clinical trials through to sample analysis and biobanking. Keeping track of samples received, where they are, who can access them and for what purpose, can be challenging. Especially if you need to monitor samples as they move between labs or you’re processing them to create aliquots and derivatives.
Governance is an essential function in all clinical research labs. You need to know that everyone is adhering to your SOPs. This includes strictly controlling access to your data and full visibility and traceability of all actions.
How Achiever Clinical Research LIMS supports your Clinical Trial, Biobank and Research teams
Achiever Clinical Research LIMS securely centralises and standardises your clinical research data and workflows to improve data quality, increase process efficiency and meet regulatory compliance.
Offering a unique combination of LIMS and CRM functionality, Achiever Clinical Research LIMS can be configured to meet diverse and complex process and data requirements using its low-code, no-code configuration tools and Laboratory Execution System (LES).
The LIMS’ Laboratory Execution System (LES) guides researchers step-by-step through your SOPs and processes to ensure consistency, reproducibility, and compliance. The low code, no code, configurable LES enables you to design and adapt workflows to meet your unique study protocols as well as your lab processes and needs.
Flexible, configurable workflows to manage sample receipt and dispatches enables you to trace all sample movements between internal and external labs. In addition, the comprehensive events audit trail and record versioning capabilities provide complete traceability across all data and activities.
Comprehensive CRM features support supplier and customer management activities as well as participant recruitment. Plus, automated communications and alerts send personalised emails, SMS and notifications to both internal and external recipients in accordance with GDPR.
Connecting to your lab instruments, scanners, and systems, the LIMS reduces data transcription errors, as well as increasing productivity by removing unnecessary administration.
Access to the LIMS is centrally managed, supporting authentication through external identity providers including PingFederate, Azure Active Directory and Active Directory. In addition, the LIMS provides ‘at rest’ AES-256 encryption of Personally Identifiable Information (PII), Role Based Access Control (RBAC) and Attribute Based Access Control (ABAC) to safeguard your data further from unauthorised access.