Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Taking Research In-House With CRIO: SciTech's Multi-Center Phase 1 Study

  Explore the success story of an early-stage clinical pharmaceutical company that effectively navigated funding constraints when conducting its Phase 1 study without a third-party CRO. 

• Expert Consulting And MRCT Strategy Rescues Oncology Program

  Uncover how this strategic approach yielded significant outcomes, including uncovering missing data through IB review, streamlining dosing timelines, and achieving successful recruitment milestones.

• Strategic Pre-IND Consulting For Gene Therapy In Rare Leukemia

  Learn about the collaborative efforts of an innovative biotech startup and Ergomed Consulting to overcome challenges in the pre-IND phase for a novel gene therapy targeting a rare form of leukemia.

• Busting The Top 7 Data Quality Myths In Clinical Trials

  Separate fact from fiction and dispel the myths about evolving clinical data collection, monitoring, and reporting by diving into this analysis of technology use in clinical trials.

• A Successful Pre-IND Enabling Next Stage Of Development

  Confronted with challenges, unearth how after receiving regulatory consulting services, this biotech was able to evaluate deficiencies in its development program, augment leadership and technical expertise in its application review, and more.

• The Digital Transformation Of A Leading CDMO's Process Development Lab

  Discover how a leading CDMO was able to create a data model for its bioreactors, resulting in easily contextualized data, time savings in manual tasks, and the ability to share insights in real time.

• Mobile Application Considerations For Clinical Trials And Beyond

  Delve into fundamental definitions, navigate through the regulatory landscape, and examine common applications of mobile apps in research.

• MilliporeSigma's 97-Day Implementation Success Story

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

• The Foundation Of Peak Performance

  In this case study, read about an underdrain system that continues to operate as expected after 16 years of operation and appears to be in perfect condition. 

• Creating Endpoint Adjudication Committees And Management Strategies

  In complying with regulations, trial sponsors may need expert guidance on best practices for developing an EAC and overall strategy and oversight of key endpoint objectives and processes.

• Controlling Trace Impurities In Chemically Defined Media

  Discover a novel approach for manufacturing chemically defined media with precision control of trace impurities that utilizes innovative raw material analysis, data analytics, and a proprietary algorithm.

• Patient-Defined Recruitment: The Movement Advanced By COVID-19

  The pandemic forced the pharmaceutical industry to reimagine how we recruit patients to clinical trials – and it's delivering significant benefits to sponsors who embrace these changes.