White Papers

1. Direct-To-Patient Clinical Trials 5/20/2022

   This paper provides a brief overview of factors underlying the rapid and ongoing modernization of clinical trials and provides a short discussion of DtP trials and demonstrates how they can solve some of the difficulties you may be facing today.

2. A Guide To Navigating CNS Clinical Trials 5/19/2022

   Discover a holistic approach to overcoming common challenges, following best practices, and conforming to FDA recommendations through a DCT model.

3. Objective Scratch Assessments Using Digital Health Technologies (DHTs) 5/19/2022

   This white paper explores how an objective scratch measure is now achievable through the use of wrist-worn wearable technology that is both non-invasive and easy to implement.

4. 2021 Completed Trials: Green Shoots Of COVID-19 Recovery Become Apparent 5/19/2022

   The COVID-19 pandemic continued to reshape the clinical trials landscape in 2021. Trialtrove recorded 4,109 industry-sponsored clinical trials from Phase I through to Phase III/IV that either reached completed status or reported primary endpoints, an 8.8% annual increase.

5. Patient-Centric Oral Solid Dose Formulation: Improving Access And Value Across The Product Lifecycle 5/17/2022

   This whitepaper provides insight into the systematic application of patient centricity to the design of OSD products.

6. mRNA Vaccine Development: Key Insights For Planning, Workflow, And Supply Chain Success 5/17/2022

   In this report, we will review key insights derived from the development of mRNA-based COVID-19 vaccines and how they can be applied to accelerate progress in the manufacture of mRNA vaccines and therapeutics moving forward.

7. Continuous Manufacturing And Late-Phase Strategy: The Time Is Now 5/17/2022

   This report discusses recent progress in continuous manufacturing and provides guidance for answering three key questions related to the implementation of continuous processing for late-phase development of small molecule oral solid dosage forms.

8. The Changing Landscape Of Oncology Drug Development: Bringing Novel Lifesaving Therapies To Patients 5/17/2022

   This whitepaper provides strategic guidance for successfully navigating such complexities, focusing specifically on: unique formulation and handling requirements, novel trial designs and the supply chain implications, and regulatory and clinical strategies to support product approvals.

9. An Innovative Approach To Patient-Centric And Data-Driven Clinical Trial Planning Using The Patient Burden Index 5/11/2022

   In this white paper, discover why reducing patient burden and improving patient experience must be driving factors in optimizing protocol design and execution in order to minimize recruitment and retention challenges.

10. Direct-To-Patient Supply: Industry Perception And Future Trends 5/5/2022

    234 individuals involved in clinical supply and operations were surveyed to better understand sponsors’ perspectives on DTP distribution of clinical supplies and interest in using it in their studies.