FEATURED ARTICLES

• The ABCs Of Transitioning PK Assays From Preclinical To Clinical

  Ensuring a seamless transition from preclinical to clinical stages in large molecule bioanalysis will help you reach crucial trial milestones on time and within budget. However, optimizing pharmacokinetics (PK) assays to bridge the preclinical-to-clinical gap requires some finesse.

• Localized Attention On A Global Scale: A Phase III Study In Early Alzheimer’s Disease

  In a recent Phase III study focusing on mild cognitive impairment (MCI) and mild Alzheimer’s disease, discover how recruitment was completed within 22 months, randomizing more than 1,800 subjects after screening more than 6,000 patients.

• Large Molecule PK Assays: Optimizing Bioanalysis For Preclinical Through FIH

  In this article, the key parameters (e.g., assay design, matrix interference, assay sensitivity and assay range) of preclinical and clinical assays are compared. Recommendations are then provided to facilitate the transfer of assays from preclinical to clinical phases.

• The Keys To Success For Achieving First To File Status

  This guide uncovers qualities to look for in a contract research organization (CRO) partner to help with your filing, challenges you may be faced with, and what success can look like when you apply these learnings. 

• CRISPR And The Commercialization Of Gene-Based Therapies

  Discover how increased collaboration between drug developers, manufacturers, and payers at the pre-commercialization stage of cell and gene therapies facilitates the development of meaningful, clinical endpoints and a viable market access strategy.

• Clinical Development Of CRISPR-Based Therapies In Oncology

  In this available white paper, examine the operational implications associated with the evolving therapeutic area of CRISPR gene editing technology in clinical trials.

• Integrated CPU And Bioanalytical Services Deliver Reduced Cycle Time And Cost Savings For Early Phase Trial Sponsors

  Explore how efficiencies are critical to the support of trial sponsors that are managing multiple-cohort trials and those that are re-examining old compounds for new applications.

• Successfully Selecting Sites For A Psychedelic Trial

  The psychedelic clinical development pipeline is growing, and competition for experienced sites has the potential to slow startup timelines. Here are a few considerations that should be explored when selecting a site with the least risk.

• A Guide On Successfully Managing An AME Clinical Trial

  Finding a partner to perform your AME studies in a reasonable time frame, let alone one with an excellent track record, may be a challenge. Discover how these challenges can be overcome in the available white paper.

• How To Build Mutually Beneficial Relationships With Advocacy Groups

  In this article, explore how even though the emphasis on patient-focused trials has increased access for patients, it has led to one-sided, transactional relationships between industry and advocacy groups

• CRISPR, Gene-Based Therapeutics, And Clinical Trials

  This series on CRISPR technology explores domains relevant to professional staff accountable for the design in the implementation of strategic clinical development programs involving advanced therapy medicinal products (ATMPS).

• 7 Solutions To Avoid Risks In Early Phase Clinical Trials

  Delve into why exceptional trial design and management expertise is needed to ensure an effective use of time and budgetary resources so that targets are met without compromising data integrity and regularly compliance.

• Proactively Addressing Access And Reimbursement Challenges For ALS Therapeutics

  In this white paper, learn why ensuring patient access to new ALS therapies requires more than regulatory approval of such therapies.

• Early Phase Rescue Study In A Progressive Rare Disease: A Personal Approach

  A biotech company needed a CRO to take over a Phase I single center, inpatient study for a progressive rare disease for a drug with an unknown safety profile. Discover how a thoughtful and strategic plan from recruitment through participation was developed.

• A Novel Approach To Early Phase Studies For Advanced Therapeutics

  Clinical research involving rare disease patients poses a number of questions about patient contact, pre-screening and screening, management, and logistics. This paper explores those questions, as well as the challenges they create, and how they can be addressed.

• Against All Odds: Phase III On A Breakthrough Therapy In Lupus Nephritis

  When a sponsor began clinical trials for their therapeutic, there were no FDA-approved treatments for Lupus Nephritis, only medications to control inflammation. With recruitment hurdles and a lack of regulatory guidance, delve into how an expert strategy was created for this pivotal Phase III study.

• Proactive Strategies For Meeting NDA Timelines Despite Last-Minute Supplemental Study Requests

  With just months left until planned submission of a new drug application (NDA), the Food and Drug Administration mandated a series of unexpected supplemental studies for a new oncology drug. Find out the results in this case study.

• Shifting Tides In Dementia Research

  According to the World Health Organization (WHO), more than 50 million people around the world currently live with dementia, and that number is growing at a rate of 10 million per year. Consider the challenges associated with this research in this white paper.

• Optimal Outcomes In Clinical Research And Product Development

  Find out why innovators turn to contract research organizations (CROs) for additional preclinical and clinical expertise and resources to help complement internal capabilities. 

• The Art And The Science Of Ensuring Inter-Rater Reliability: Clinician-Related Outcome Assessments In Orphan Disease Research

  This article focuses on clinician-rated outcome assessments (ClinRos), some of which may be novel; others may be well established and familiar to individuals practicing in clinics and research settings alike.