The transition from preclinical to clinical testing is a pivotal moment in drug development. It’s also one of the most challenging development milestones, beset by unknown risks, unexpected data, and potential regulatory hurdles to overcome. In this article, Quotient Sciences experts discuss how proper planning can avoid missteps in first-in-human studies, looking at trial design, CMC, and regulatory considerations.
Quotient Sciences is dedicated to Phase I trials and early drug development, providing the insights you need by offering comprehensive clinical pharmacology services for all Phase I study programs. Our services encompass expert clinical study design, thorough data analysis, and detailed reporting. With our fully integrated approach, we ensure seamless execution and deliver high-quality results safely and quickly.
Partnering with an experienced first-in-human specialist such as Quotient Sciences is the key to navigating early development with confidence. Through our work with small molecules and biologics, we provide the expertise, infrastructure, and agility needed to move your novel therapy forward, faster.
Dr. Andreas Reichl, Senior Drug Development Consultant, and Dr. Kevin Schaab, Senior Drug Development Consultant, both from Quotient Sciences, present a practical breakdown of how early-phase experts design programs to mitigate risks and efficiently move novel molecules into PoC assessments.
This case study highlights Quest Diagnostics' successful and cost-effective patient recruitment for The Michael J. Fox Foundation's Parkinson's study. By using its extensive patient network, Quest engaged a large, diverse group for research into early disease indicators, effectively overcoming significant recruitment challenges.
This datasheet illustrates how Quest Diagnostics' extensive de-identified lab data can be leveraged to accelerate and optimize clinical trials for breast cancer research. Researchers can use this real-world data to identify high concentrations of eligible patients, select optimal trial sites, find suitable principal investigators, and drive targeted patient recruitment efforts.
This datasheet illustrates how Quest Diagnostics' extensive de-identified lab data can be leveraged to accelerate and optimize clinical trials for Chronic Kidney Disease (CKD). Researchers can use this real-world data to identify high concentrations of eligible patients, select optimal trial sites, find suitable principal investigators, and drive targeted patient recruitment efforts.
This datasheet illustrates how Quest Diagnostics' extensive de-identified lab data can be leveraged to accelerate and optimize clinical trials for colorectal cancer research. Researchers can use this real-world data to identify high concentrations of eligible patients, select optimal trial sites, find suitable principal investigators, and drive targeted patient recruitment efforts.
The clinical trial landscape is evolving at an incredible speed. The challenges are real; rising costs, data overload, and complex protocols can slow your progress. But what if you could face these challenges and turn them into a competitive advantage?
Clinical trials frequently struggle with challenges due to slow enrollment, poor patient retention and operational delays, which can result in rescue studies. Learn how Quest Diagnostics and PatientsLikeMe revitalized a stalled lupus rescue study through a data-driven recruitment strategy and a patient-centric engagement approach.
When drug developers choose the right outsourcing strategies in clinical research, they can gain significant benefits in terms of quality, efficiency, and operational success. In its third annual Functional Service Provider (FSP) Trends Report, Thermo Fisher Scientific’s clinical research business—PPD—gathered insights from 150 global biotech and pharma leaders to determine how FSP models help sponsors address common industry obstacles.
Leveraging data-driven patient and healthcare provider (HCP) insights, including social drivers of health (SDOH), is essential for life sciences companies to continuously improve patient engagement and commercial success. Mark Rodgers, AVP of Commercial Analytics at Inovalon, discusses how identifying treatment milestones, assessing HCP performance, and segmenting patient populations using SDOH data can drive targeted strategies that improve healthcare outcomes and market access
We are amidst a data revolution in healthcare and the life sciences. With advances in DNA sequencing, multiomics, wearables, imaging, and clinical data capture, there is more data — and there are more data modalities — to draw from for biomedical research than ever before. However, the quantity, variance and speed of data generation outpaces researchers’ ability to effectively utilize it to reveal medical breakthroughs for those in need. The ability to analyze health data is critical in developing a precision health approach. By leveraging diverse data sources, researchers can determine the most effective actions for individuals and communities. However, current barriers to data access and collaboration hinder progress. To accelerate the pace of discovery, a solution is needed to close the gap between research and health care. This paper describes how Verily Workbench provides solutions for healthcare professionals and researchers to easily access and collaborate on data within an integrated analysis and governance framework. Workbench provides a community of researchers with the platform, data, and tools to solve the most pressing scientific challenge
Learn how Quest can help connect highly qualified patients to a clinical trial with precision identification and direct to patient outreach
Clinical trials have become increasingly complex over the past decades, making participant recruitment more challenging than ever. This guide explores common recruitment obstacles and offers strategies to overcome them using a patient engagement and recruitment solution.
According to a 2024 study “Benchmarking Site Activation and Patient Enrollment,” 33% of sites under-enrolled, and 14% failed to enroll a single patient. The best way to course-correct this is to adopt a multifaceted approach to patient recruitment, that goes beyond traditional channels and ways of thinking.
Watch Citeline’s 15-minute presentation from Clinical Leader’s Patient Engagement & Recruitment Solutions Expo, where VP Matt Holms explores Direct-to-Data (DTD) patient recruitment. This session takes a deep dive into how complex algorithms, tokenized data, and large data assets can optimize enrollment, highlighting the importance of early strategic recruitment planning and breaking down the unique benefits and real-world applications of DTD.
Dr. Peter Wahl, MLA, MS, ScD, VP and Global Head of Scientific Affairs at CorEvitas, part of the PPD™ clinical research business of Thermo Fisher Scientific, discusses the critical role of protocol-driven registries in generating regulatory grade RWE to serve multiple and evolving evidence needs across the drug development life cycle. He covers key considerations for selecting the right type of registry, explains why registry data is the gold standard in RWD, and how it contextualizes safety and effectiveness to fulfill FDA and EMA post-marketing requirements.
Market Data Analytics Buyer's Guide - Are you considering a medical claims data solution for healthcare business planning and strategy? Here’s how to make sense of the options.
A pharmaceutical company aimed to launch a Phase III clinical trial for a new oncology drug, focusing on efficient and effective patient recruitment across diverse regions. They evaluated patient populations by analyzing demographics, social determinants of health, and geography. Investigator profiling included practice details, affiliations, referral networks, and clinical trial experience. The final step involved selecting and extracting target lists for implementation.