Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Accelerated Peptide Drug Development And Clinical Strategies

  Review how an integrated platform approach and innovative filtration strategies helped bring a novel therapeutic to Phase 1 clinical trials with reduced time and costs.

• Advancing Rare Disease Clinical Trials With Point-Of-Need Eye Assessments

  During the COVID-19 pandemic, Applied Genetic Technologies Corporation (AGTC) faced significant hurdles in enrolling participants due to travel restrictions and site limitations.

• 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.

• 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.

• Are You Leveraging All Of Your Clinical Data?

  To develop and execute a successful clinical strategy, trial sponsors must be able to rapidly acquire detailed data insights. Learn how you can better utilize your trial data and achieve greater insights.

• Microbial Challenge In-Use Studies

  Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.

• 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.

• Building A High-Quality IND From Scratch With Strategic Gap Analysis

  A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

• A Race Against Time: Startup Partners With Donatelle For Novel Class III Device

  In a race against time, a startup takes advantage of Donatelle’s pure medical expertise and vertical integration for the development of a novel Class III device.

• Avoiding The Pitfalls Of PQR

  Explore the fundamentals of Product Quality Reviews (PQRs), common challenges manufacturers face, strategies for streamlining PQRs, and solutions that aim to unlock the potential of a "real-time PQR."

• 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.

• 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.