Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• 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.

• 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.

• eSource Purpose Is Not Just To Complete The EDC

  Central eSource transforms data capture from a passive, back-end chore into an active, real-time quality and compliance engine—delivering benefits that extend beyond faster EDC feeds and reduced SDV.

• Aseptic Filling Solution Enhances Sterility Assurance for Pharma Manufacturer

  Emergent BioSolutions upgraded its Winnipeg site with the Cytiva SA25 aseptic filling workcell to improve sterility assurance, product flexibility, and regulatory compliance for CGT manufacturing.

• Challenges And Solutions In Lyophilization Development For ADCs

  Successful ADC lyophilization requires a robust, individualized process driven by thermal characterization using DSC and FDM to define the critical parameters for stability and efficient manufacturing.

• Pioneering The End-To-End Decentralized Trial Experience

  This collaboration highlights the potential of decentralized clinical trials (DCTs) to transform trial execution, as well as offering a replicable model for future research.

• 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.

• Rescuing A Global Program For NDA Success

  Explore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.

• How To Manage A Drug Product In A Medical Device Environment

  Discover how ProPharma successfully ensured GMP and GDP compliance for a drug product within a medical device environment.

• Partnering For Precision In An IPF Study: Securing Timely Deliverables And Key Endpoints

  A pharmaceutical company enlisted Worldwide Clinical Trials to help achieve on-time results for their Phase IIa IPF clinical trial, enabling them to manage vendors and meet challenging deadlines.

• Improving Patient Health And Safety

  Engage an experienced CMC program management consultant to collaboratively develop and maintain a robust product development plan (PDP) with your team lead, cross-functional members, and vendors.

• Advancing Dose Escalation Strategies With Bayesian Modeling

  A CRO was engaged to help a biotechnology sponsor develop a novel oncology therapy design and execute a multicenter, open-label Phase 1/2 dose escalation and expansion study in advanced solid tumors.