Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• A Strategic Guide For Biotech And Biopharma Leaders

  Securing drug approval is a complex, high-stakes process, and outdated review workflows hinder progress. Explore modern solutions that accelerate timelines without compromising compliance or quality.

• Applying A Platform Approach To Bispecific Antibody Development

  Explore how experts were able to adjust a mAb production and purification platform to be applicable for the rapid development and scale up of a BsAb.

• 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.

• Testing For Coexistence In Crowded And Contested RF Environments

  In this paper, we review some of the key research, development, test and evaluation (RDT&E) challenges that arise when developing and deploying systems that need to operate in congested and/or contested RF environments.

• RNA: The Next Era In Therapeutic Development

  Review the unique set of challenges for RNA production that must be considered and solved to reach their full therapeutic potential.

• 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.

• 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.

• Navigating The Translation To Clinic: Future-Proof Your Plasmid Products

  Future-proofing products with strategies that reduce risk and timelines for later stages can be resource-intensive but add significant value. Explore the challenges encountered progressing from development to clinic.

• Mobile Research Units Enable Large Volume Screenings

  Learn how recruitment and screening of potential patients was made possible for a Phase 3, adult patients, clinical trial by utilizing MRUs to screen large volumes of patients at community events.

• CRO Leverages Integrated Central IBC Partnership To Initiate Sites

  Learn how a CRO was able to accelerate review times so COVID-19 vaccine trial sites could progress through site selection, IRB/IBC submission, approval, drug shipment, and complete site initiation visits in record time.

• The Role Of The Technical Transfer Executive Sponsor

  Explore the importance of understanding a CDMO’s flexibility and culture, models and scale of equipment, technical capabilities, regulatory support, quality system, and executive sponsorship model.

• Streamline Recruitment With Confidence

  Transform your clinical trial recruitment with a service that delivers faster, more cost-effective enrollment, particularly for hard-to-reach populations.