Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• The New Industry Migration Framework For FSP

  Review why a functional service provider should be on the top of a sponsor’s list when it comes to choosing a specialized eClinical data management provider for its next study.

• 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.

• Research Site Network Enhances Study Startup With Reliable ICF Writing Services

  With help from a new informed consent form (ICF) writing partner, discover how CenExel Clinical Research was able to streamline processes and launch new studies faster.

• Project Management And Strategic Planning Services

  Read about the steps that led to a progressive drug design and development organization gaining approval to begin manufacturing its new, real-time release, OSD drug in-house.

• How To Facilitate Good Clinical Data Review In Your Clinical Trial

  Learn how to create a system based on connectivity and automation, aggregated and usable data, flexible analysis, and methods of collaborative data review by centralizing analysis and communications.

• On-Demand Payment Technology Offers Accuracy, Speed, & Transparency

  Review current grant payment practices and how new software tools can transform the process, efficiently solving the problem that first gave rise to sponsor-funded escrow accounts.

• Response To FDA Black Box Warning

  The FDA has launched an investigation into the risk of T-cell malignancies following CAR-T cell immunotherapies. Review the key points of this announcement concerning the CGT research community.

• Regulatory Considerations For Excipients Used In Lipid Nanoparticles

  Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

• 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.

• 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.

• Success Factors For Launching Products With Orphan Drug Designation

  Orphan drug designation offers a number of financial incentives to pharmaceutical companies. Learn more about the potential hurdles of orphan drug development and the opportunities to maximize your success.

• Retrofit Of A Brand New Pump Station

  Due to clogging problems, a pump station was experiencing reduced pump performance, longer pump run times, significant vibration issues, and the need to be physically unclogged.