Is your regulatory team ready for the next FDA Deficiency Letters? FDA’s Center for Devices and Radiological Health (CDRH) reports over 55% of 510(k) submissions receive at least one Additional Information or Deficiency Letter—often due to missing data, unclear testing, or labeling issues. Across the product lifecycle, from preclinical to
The Gitnux 2025 Compliance Statistics report found that 59% of compliance breaches are caused by human error, and 40% of organizations experience difficulty in tracking compliance documentation after audits. With increasing complexity, growing cyber risks, and the high cost of manual processes, businesses are under pressure to enhance compliance frameworks.
In 2025, as pharmaceutical sponsors push for faster, more efficient, and patient-centric drug development, CROs must move beyond traditional service delivery models. Embracing digital-first strategies is essential for staying competitive, compliant, and connected to the needs of patients and regulators alike. This article explores the top five digital transformation priorities
The transformation of clinical trials into efficient, compliant, and patient-focused ecosystems is no longer a future ambition — it’s happening now, decisively driven by automation. In today’s fast-evolving healthcare landscape, automation isn’t optional. It’s a strategic necessity that eliminates hidden costs, reduces manual inefficiencies, and accelerates Clinical Trial Time from
Smarter Clinical Trials with AI in SDTM Automation 50% of biopharmaceutical professionals identified either the variety of data types (26%) or lack of standardization (24%) as their primary challenges when dealing with external data sources in clinical trials. In clinical research, data consistency is the key to seamless operations and
How AI in Patient Recruitment Cuts Trial Timeline? According to a Tufts CSDD report nearly 80% of clinical trials fail to meet enrollment timelines. Can AI (Artificial Intelligence) in patient recruitment be a game-changer in identifying eligible candidates faster, improve diversity, and reduce dropout rates? This blog explores the challenges
PII Redaction is the process of removing personally identifiable information (PII) from medical records and other documents. Almost 15 million Americans become victims of identity theft each year. Redaction of personal data helps to protect an individual’s identity and ensure data privacy. Why PII Data Redaction is Important Before Clinical
From robust documentation requirements for shipment validation to preventing invoice duplication, life science sector employees are riddled with time-consuming challenges that can quickly become chaotic. From lab managers to finance leaders juggling POs across multiple tools and manually through spreadsheets is unproductive and error prone. In fact, scientists in life
Mastering Budget & Coverage Analysis In the intricate world of clinical research, the importance of accurate budget and coverage analysis cannot be overstated. As protocols become more complex and studies expand across multiple sites and countries, the financial backbone of a clinical trial needs to be rock-solid. A single misstep
