Newsletter | July 26, 2021

07.26.21 -- The Right Precision Medicine Partner Is Essential For Trials And Patients

Featured Editorial
Industry Insights
How Open Approaches And Interoperability Enable A Better Ecosystem For Clinical Trials
As pharma companies and CROs around the world continue to adapt to running trials in this new COVID-19 environment, they are taking this time to reassess the status quo of their technology installations. It’s times such as this that you can really delve deep into assessing how “open” or “interoperable” a system really is.
Challenges In Glioblastoma Studies

Over the past decade, our neurologists, oncologists, and clinical team experienced firsthand shifts in this research space. We understand the specific challenges in treating and researching this population and apply our medical and operational expertise when designing and implementing glioblastoma trials. Here is how we are applying our 20 years’ of oncology trial experience to help find new therapies.

Real-World Data Enhanced Clinical Trial Design

With expanding support from the FDA, the use of routinely collected clinical data at the point of care — real-world data — is becoming a promising tool for research teams. The interest in real-world data has skyrocketed but knowing when and how to use the data has been an adoption hurdle for the industry. This blog explores three use cases particularly appropriate for real-world data: synthetic or external comparators (SCA/ECA) to replace or augment standard controls, precision registries for adaptive trial design, and clinical trial site feasibility to improve patient enrollment and recruitment.

Exploring Clinical Trial Design And Data Collection In A New Environment

New research reveals that COVID-19 has accelerated adoption of decentralized approaches and remote data collection for clinical trials and that this transition that has come with both challenges and benefits.

Planning The Way Forward In Neurodegenerative Disease Studies

The Food and Drug Administration (FDA) recently released specific draft guidance, Human Gene Therapy for Neurodegenerative Diseases (ND). This guidance provides recommendations for sponsors who are developing human gene therapy (HGT) products for neurodegenerative diseases, which affect adult and pediatric patients. It focuses on considerations for product development, preclinical testing, clinical trial design, and marketing approval pathways. This article outlines several areas to consider when preparing for regulatory agency interactions.

It’ll Take New Tools And Partnerships To Fast-Track Clinical Trials For A COVID-19 RX

The industry needs new tools, technologies, and partnerships to collaborate virtually on clinical trials for COVID-19 treatments.

Identifying Choice Trial Designs Using Pareto
Economists have long used the concept of Pareto Efficiency to refer to the optimal allocation of resources with respect to a set of preference criteria. This position paper reviews how the idea of Pareto Efficiency, also called Pareto Optimality, can be used for the strategic selection of a clinical trial design, rapidly identifying which designs are most aligned with an organization’s business goals, such as speed-to-market, savings in development costs, and likelihood of success.
Enabling Fast, Appropriate Drug Product Supply For Phase 1 Clinical Trials

Without the ability to move smoothly from lab concept to manufacture to delivery of GMP clinical supplies to patients, critical milestones could be missed, delaying funding commitments from investors.

How Leveraging Cross Collaboration Can Improve Standardization And Adoption Of An eRegulatory Solution

The University of Cincinnati Cancer Institute (UCCI) collaborated with the UC Health Office of Clinical Research (OCR) to roll out an eRegulatory system based on an NCI Standard from Complion. This allowed for enhanced compliance with ability to identify trends and gather quality metrics across UCCI disease groups and OCR departments to inform business decisions and process improvements.

Current Data Privacy Regulations Impacting The Life Sciences Industry

The General Data Protection Regulation (GDPR) is a significant advancement of consumer data protection rights. The European member states agreed to a set of principles that would penalize organizations that don’t safeguard personal identifying information (PII). If your team or clinical trial operates in the EU, California, S Korea, Australia, or a dozen other countries, your data could be subject to strict privacy laws. Violating GDPR, PIPA, APP, or CCPA, among others, have serious consequences for your program. Learn how to mitigate risk and keep on the right side of regulators.

Industry Perspective On Streamlining Information Sharing

Clinical operations leaders reveal an urgent need to improve information exchange between sponsors, CROs, and sites. Veeva’s vice president, Veeva Site Connect, Jason Methia, shares a summary of the findings in this vlog.

U.S. Clinical Labels 101: Steps To Ensure Accuracy

Determining a drug candidate’s probability of commercial success is a most significant phase in the drug development process. There is no room for error.

Pros And Cons: Defining Site Expertise Across Veteran And Research-Naïve Sites

Clinical sites that have a great deal of experience are generally sought after, but they can often be busy running other trials. It may be beneficial to consider less experienced sites in order to have more trial options. But of course, there are some necessary considerations when turning to these sites.

Overcoming Common Challenges Of Clinical Data Review

Clinical data review is an intrinsic component of clinical development aimed at assuring patient safety, determining drug efficacy, and assessing data quality. It involves rigorous analysis of a broad variety of clinical trial data and often necessitates integration of data from multiple sources to extract actionable insights. Here, we look at some of the main challenges of clinical data review and discuss effective strategies to address these, before explaining how our solutions can be deployed to bring urgently needed therapeutics to patients faster.

5 Tips To Streamline And Improve Patient Recruitment And Enrollment

Clinical trial recruitment is one of the biggest bottlenecks in clinical research, jeopardizing data quality and development timelines. Read how these five strategic key tips can broaden access to and encourage participation in the development of new medicines, devices, and vaccines.

Improving Access To Research For Diverse And Underserved Populations

Increasing diversity and inclusion in research has long been a challenge in the clinical research community. This paper shares unique perspectives from industry experts regarding barriers and strategies for improving access to research for diverse and underserved populations with approaches ranging from grassroots community efforts to enterprisewide initiatives spanning large research sites and CROs.

How To Select The Best Courier Around The Globe

As a leading biotechnology company's pipeline and global presence continued to grow, management of the supply chain presented challenges. Additionally, cost pressures demanded a tighter supply chain with better control over inventory levels, and there was a need for increased temperature monitoring of clinical supplies in transit. Learn how data-driven decisions allowed them to realize cost and performance improvements across the supply chain.

Pharma Sponsor Enlists Cenduit IRT To Rescue A Multicountry, Multisite Oncology Study

After go-live, the sponsor learned its study did not fit the existing interactive response technology (IRT) solution, affecting data quality, timelines, and drug supply shipments. The legacy system’s medication management algorithm could not support the required flexibility in the supply chain. The trial included an adaptive cohort design. Read how Cenduit delivered a high-quality study achieved through innovation, close client collaboration, and expert project management.

A Multidisciplinary Perspective On Decentralized Study Design

The biopharmaceutical industry is rapidly adopting methodologies that decentralize research by harnessing transformative data acquisition and patient engagement thus taking the research beyond the walls of the legacy study setting. To truly realize the promise of decentralized research models, a dynamic array of technological capabilities, traditional research core competencies, and innovative study design expertise is required. Join us as we explore operational challenges, technical solutions, and design considerations.

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