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WHITE PAPERS AND CASE STUDIES

• How Digitized Protocols Are Accelerating Clinical Research

  Digitized protocols, enhanced by artificial intelligence (AI), are transforming clinical trial operations by accelerating document generation, system integration, and trial optimization.

• Streamline Analytical Tech Transfer Through Analytical Target Profile

  Analytics debt in CGT can derail timelines and budgets. Learn how early ATP planning and cross-functional alignment can eliminate costly setbacks and accelerate IND approvals.

• Deal-Making Volume Slowed In 2023

  This report provides an overview of alliance, merger and acquisition, and financing deal activities across the global biopharma, medical device, and in vitro diagnostics industries in 2023, as reported by Biomedtracker.

• Connecting Quality Management, Patient-Centricity, And Business Value

  Examine why organizations must integrate data and processes to enhance quality and insights to improve operational efficiency, patient health, and regulatory compliance.

• Guide To Pharmaceutical CAPA And Quality Management

  CAPA management is vital for quality systems, especially in pharmaceuticals. Examine how issues are identified, corrected, and prevented to safeguard health and uphold regulatory compliance.

• Best Practices For Internal Quality Audits In Life Sciences

  Discover why internal quality audits are vital in the life sciences sector to ensure regulatory compliance, mitigate risks, and maintain high standards of product quality and patient safety amidst evolving challenges.

• Building A High-Quality IND From Scratch With Strategic Gap Analysis

  A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

• The Evolution Of EAM/CMMS In Pharma Manufacturing

  Explore pharma’s shift from paper-based maintenance to modern EAM/CMMS that shows how digital tools boost compliance, reduce downtime, and improve data accuracy and productivity.

• Relieving The Strain Of Publishing During Regulatory Registration

  Go inside how an expertly handled NDA submission for a biopharma company ensured timely FDA approval despite challenges.

• Challenging PFAS-Impacted Industrial Wastewater Reduced To Non-Detect

  ECT2 was approached by a remote refinery in Alaska that had found PFAS in their wastewater stream.

• A CFO's Guide To Driving Growth

  Navigate the evolving biotech landscape and secure venture capital with insights on strategic partnerships and investor expectations.

• Operationalizing Disclosure Intelligence For Compliance At Scale

  Learn how sponsors can transform compliance functions into unique strengths, not only meeting regulatory requirements but also uncovering strategic opportunities in this challenging landscape.