ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Overcoming The Challenge Of Maintaining Sterility At Low Temperature Storage

  Learn about a biotech company with a recently approved gene therapy product that needed to select a packaging solution to meet their needs for storage at low temperatures and still get to market quickly.

• Manual Assembly Strategies For Early‑Phase Combination Product Supply

  Early‑phase combination products rely on manual assembly. Clear process design, quality controls, and collaboration help clinical supply teams reduce risk and maintain trial‑ready flexibility.

• Treating Deficiencies In Employee Training And Mentorship

  Investing in employee training and development is not just beneficial for the employees. It also contributes significantly to the organization’s success and competitive advantage.

• Key Considerations For Emerging Companies When Selecting Packaging Components

  Recognizing the importance of packaging development and prioritizing its role in drug development early on can help proactively identify potential delays and overcome risks.

• RTSM And Clinical Drug Dispensation

  A pharma company used Signant Health's RTSM solution in a Phase 2 schizophrenia trial to ensure drug availability, maintain study balance, prevent duplicate allocations, and manage returns and destruction of unused drugs.

• Writing Effective Clinical Regulatory Documents For Therapy Trials

  Clinical medical writing for gene therapy regulatory documents is a demanding, detail-oriented task that diverges significantly from medical writing for more traditional therapies.

• IRT: A New Approach To Meeting The Needs Of Early Phase Trials

  As early phase clinical trials become more sophisticated, sponsors are now leveraging flexible IRT solutions to replace error-prone manual processes and gain greater control and efficiency.

• IMP Labeling: EU CTR Transition Considerations

  Review current requirements as outlined by the EU Clinical Trial Regulation, supporting guidance, and three key considerations when planning IMP labeling activities for ongoing studies.

• From Frustration To Organization: An SSO Platform For Trial Sites

  To reap the benefits of tech innovation, sponsors and sites need a single sign-on (SSO) solution that enables streamlined organization across different trials and clinical systems.

• Logistics, Transport Challenges Require Complex Solutions

  The pandemic created additional obstacles for the clinical supply chain. Ensuring continued clinical trial operation requires an optimal management solution for clinical material supply.