Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• 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.

• Reducing Risk And Timelines In Cell Line Development

  Accelerate your biologic development by adopting faster, more reliable clone selection methods that reduce time and resources while improving the likelihood of identifying stable, high-producing cell lines.

• Supporting A Company In Manufacturing The RSM For Treating A Rare Tumour

  A clinical-stage oncology company needed a partner to manufacture the RSM. Examine how an optimized RSM manufacturing process helped deliver safe, effective treatment on an accelerated timeline.

• Improving Patient Health And Safety: Medical Safety Scientist

  See how this experienced safety scientist managed benefit-risk assessments and pharmacovigilance while streamlining product development and lifecycle management for a pharmaceutical company.

• Biostatistics And Programming — More Than Just Clinical Trials

  See how our biostatisticians and programmers successfully ingested, cleaned, and analyzed the data, ultimately providing a small biotech company with several interesting and actionable measures.

• The State Of Global Clinical Trial Disclosure

  See what industry organizations are saying about trial transparency, regulations by region, what penalties are on the books, and whether they are enforced.

• The Benefits Of End-To-End Formulation And Fill/Finish Of Biologics

  Proper formulation development has a huge impact on whether a technology transfer to clinical phase fill/finish is successful. Review the challenges of transitioning a promising drug candidate.

• Case Study: Recruiting Pediatric Ultra-Rare Disease Patients

  Explore how Rezolute was able to overcome challenges while recruiting pediatric patients for a Congenital Hyperinsulinism (HI) clinical trial using a streamlined, single-source tool.

• CRO Leverages Partnership With Integrated Central IBC To Initiate Sites

  Discover how a CRO was able to reduce study startup timelines and deliver trial results to the sponsor quicker than expected.

• Container Selection For A Highly Sensitive Drug Product: A Success Story

  Learn about the importance of selecting the right container for sensitive drug products and how close collaboration is crucial for avoiding commercialization delays and safety risks to patients.

• A Successful Full-Service, Randomized Pancreatic Cancer Phase II Trial

  Learn how a clinical-stage biopharmaceutical company was able to reach a unanimous decision after a safety review committee data review meeting to close Phase II and advance to Phase III.

• MilliporeSigma's 97-Day Implementation Success Story

  Read how MilliporeSigma transformed validation processes with a digital validation system to achieve compliance in just 97 days, as well as learn key takeaways from their swift transition.