When evaluating core clinical research platforms, most companies naturally start with the well-known enterprise brands. They are recognizable, widely adopted, and often positioned as the “safe choice” for regulated environments. But once the demo phase is over and implementation actually begins, many teams discover that choosing a platform involves much more than brand recognition and […]
Vendor oversight has always been part of clinical trial compliance, but ICH E6(R3) has significantly raised expectations for sponsors and technology vendors alike. The updated guideline makes one thing very clear: sponsors remain fully responsible for trial quality, patient safety, and data integrity — even when activities are outsourced to external vendors. This includes ensuring […]
We are looking for seasoned Senior Project Manager who is ready to take full ownership of high-impact projects. At our core, we value delivery over slides and results over rigid hierarchy. Our product is a SaaS eClinical platform designed for managing clinical trials and various business processes in the pharmaceutical industry. Our clients include biotech and pharmaceutical companies, as well […]
CROs work in a fast-moving and highly complex environment. They manage multiple studies at the same time, often for different sponsors, across different countries, sites, and timelines. Each study comes with its own processes, reporting needs, and regulatory expectations. As this complexity grows, it becomes harder to keep everything aligned using separate tools or spreadsheets […]
Risk management used to live in spreadsheets, scattered documents, and endless review meetings.Not anymore 👀 That’s exactly what our QA Director, Anna Petrovskaya , will be speaking about at the International QA Virtual Conference. Her session,▶️ “Risk Management Automation in the GCP R3 Era,”will explore why traditional, document-based risk management approaches are no longer enough, and […]
We’re heading to Barcelona for OCT 2026. And this time, we’re bringing a real story with us! Our colleague Evgenia will be speaking alongside Jaume Costa from SOLTI, our dear client and long-term partner, about the question many teams still struggle with: Who should own your eClinical systems: sponsor or CRO? Stream B: AI & […]
Blinded studies are critical for maintaining the integrity of clinical trials. But while the concept is straightforward, the operational reality is often anything but. For many clinical teams, managing blinding means dealing with: This creates a constant burden: Even with strict processes in place, a single misconfiguration can compromise the entire study. TMF Blinding in […]
Financial management is critical because CROs must ensure that clinical trials remain within budget while generating expected revenue. Without proper financial oversight, organizations may experience delayed payments, incorrect invoicing, or reduced project profitability. A CTMS helps CROs maintain financial control and improve operational efficiency. Financial management is one of the most complex operational areas for […]
For decades, the clinical research industry operated under a manual, labor-intensive oversight model. The gold standard was 100% Source Data Verification (SDV) – a process where Clinical Research Associates (CRAs) traveled to sites to painstakingly cross-reference every data point in a Case Report Form against medical records. However, as trials have become more data-saturated and […]
MapLight Therapeutics selected Flex Databases to support its clinical trial operations with an integrated CTMS and eTMF platform. In this interview, the MapLight team shares why they chose Flex Databases, which features stood out during the evaluation process, and how the platform will support efficient trial oversight and long-term clinical operations. What were the key […]
The Flex Databases team is seeking an ASP.NET Developer to join one of our Software Development teams. Our product is a SaaS eClinical platform designed for managing clinical trials and various business processes in the pharmaceutical industry. Our clients include biotech and pharmaceutical companies, as well as Contract Research Organizations (CROs) that outsource clinical trial […]
We are driven by a mission to make a meaningful impact in the Life Sciences industry. We provide flexible e-Clinical software systems for Clinical Research Organizations (CROs) and pharmaceutical companies worldwide. Key Responsibilities Requirement Gathering & Documentation: Collaboration & Communication: Process Improvement & Mentorship: Client Engagement: Typical Tasks: Formalizing change requests from customer consultations into […]