Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Mobile Lab For A Large Pharma Client

  Completed in 2021, learn how this custom BSL-3 mobile laboratory received PHAC approval and ensured a secure environment for PPD powder-related MTech development work.

• Avoiding The Pitfalls Of PQR

  Explore the fundamentals of Product Quality Reviews (PQRs), common challenges manufacturers face, strategies for streamlining PQRs, and solutions that aim to unlock the potential of a "real-time PQR."

• Expert Guidance For EU Gene Therapy And Companion Diagnostic Trial Regulations

  This playbook provides a concise yet comprehensive roadmap for navigating Europe’s multifaceted regulatory environment when conducting gene therapy trials involving GMOs and CDx.

• Project Orbis Drug Registration 2025

  Project Orbis helps streamline the review and approval of oncology medicinal products through international regulatory collaboration. Learn how this framework can accelerate your regulatory strategy.

• Choosing The Right Platform: A Comparison For Regulated Industries

  Regulated industries depend on tightly controlled review workflows, yet common tools rarely meet those demands. Explore how purpose‑built solutions strengthen compliance and help streamline timelines.

• The Business Case For EHR eSource In Clinical Trials

  Examine how manual data collection challenges prompted the adoption of an eSource solution that streamlined data entry, saving time and costs, reducing errors, and accelerating a multicenter phase 2 trial.

• Best Practices For Harmonizing Global Data Disclosure

  Learn how sponsors can address the challenge of submitting clinical trial data in a consistent and compliant manner by examining internal processes to identify and close gaps.

• Authentic Engagement: Reaching Underserved Lupus Patients

  By partnering with the ICLF, see how we were able to gain access to and build trust with influential community leaders and advocates within the African American communities located near study sites.

• Manufacturing Transfers: Delivering 140+ Precision Medical Devices Without Missing A Deadline

  Go inside a successful manufacturing transfer of over 140 Class-III silicone medical devices and on-time delivery for a top-30 OEM through expert project management and rigorous validation processes.

• Advancing In Silico Predictions In Early Drug Discovery

  Examine a high-throughput approach that streamlines LogD measurements, offering faster and more accurate insight into compound lipophilicity to support better decision-making in early drug discovery.

• CDMO Accelerates Contract Manufacturing With Electronic Batch Records

  A prominent CDMO sought a specialized software solution to streamline and accelerate its manufacturing processes, enabling the efficient production of complex, customized products in record time.

• Rescuing A Global Full-Service Phase III Trial For A Late-Stage Oncology Biotech

  This case underscores the expertise employed in a comprehensive strategy and set of services that were used to salvage a Phase III clinical trial for ovarian cancer and ensure its timely completion.