Blog Post Life Sciences Quality + Compliance The FDA Real‑Time Clinical Trial Model: Why Sponsors Must Rethink Their Operating Systems Now Real-Time Clinical Trials (RTCT) are no longer a future concept; they are the first sign that today’s operating models will need ...
Blog Post Quality + Compliance Life Sciences Managing Quality-Critical Collaboration Across External Partners Communication serves as a vital role for the successful implementation and maintenance of business processes, whether they are internal, external, manual, or electronic. Most large life sciences organizations have ...
Blog Post Life Sciences Quality + Compliance Building Strategic Roadmaps for Clinical Operations Clinical trial operations today face rising complexity, driven by increasingly complex protocols, novel modalities like RNA, hard‑to‑find patients, competitive landscapes, and accelerated time‑to‑market expectations. Decentralized ...
Blog Post Artificial Intelligence (AI) Pharma FDA Issues Warning for Inappropriate AI Use: What Pharma Manufacturers Need to Know On April 2, 2026, the Food and Drug Administration (FDA or Agency) issued a warning letter to Purolea Cosmetic Lab identifying significant violations of Current ...
Case Study Life Sciences Data + Analytics Developing a GMP Data Integrity Training Program for a Biotech Company Clarkston Consulting partnered with a biotechnology company to develop a comprehensive GMP data integrity training program. Read a synopsis of the ...
Blog Post Quality + Compliance Life Sciences Embedding Intelligence into Regulated Work with Veeva AI Life sciences organizations are operating in an environment where regulatory expectations continue to rise, and data volumes continue to grow. Global operations only add to that complexity. In ...
Blog Post AMS Quality + Compliance Exploring the Benefits of a CSV Managed Services Partner Ongoing Computer System Validation (CSV) / Computer System Assurance (CSA) activities are critical in biopharma to ensure that GxP systems remain fit for intended use throughout ...
Case Study Life Sciences Pharma Application Managed Services Provider Infrastructure Qualification Project In this application managed services provider case study, Clarkston Consulting partnered with a biopharmaceutical company developing, manufacturing, and marketing regenerative ...
Blog Post Life Sciences Quality + Compliance Leveraging CSA Principles for AI Validation As pharmaceutical companies explore the use of artificial intelligence (AI) across GxP-regulated processes, many find themselves stalled in pilot phases ...
Multimedia Life Sciences Quality + Compliance 2026 Lab Informatics Trends Download the full 2026 Laboratory Informatics Trends Report here. This free trends report outlines industry perspectives and expert advice from ...
Multimedia Consumer Products Quality + Compliance 2026 Quality + Compliance Trends Download the full 2026 Quality + Compliance Trends Report here. This free trends report outlines industry perspectives and expert advice from our ...
Case Study Quality + Compliance Consumer Products Standardizing Quality Management Business Processes in S/4HANA Clarkston Consulting supported a global consumer products manufacturing company with their S/4HANA quality management business processes. Read a synopsis of ...
