Study Start-Up

Clinical Research: Phase 1 - Phase 4

Study Start-Up: Why You Really Need to Get This Right

You get one chance to initiate a clinical trial. Botch the start-up and you’ll expend great effort correcting course and playing catch-up. The waste of money and time — commodities that are chronically scarce among the biotech and specialty pharma companies that comprise most of our customer base — can be devastating. That’s why we...

Study Start-Up

Premier Insight 275: Streamlining Regulatory Submissions for a Novel Advanced Therapy Medicinal Product Trial

Background The European regulatory landscape for advanced therapy medicinal products (ATMPs) is complex and the approval pathway depends on product classification. The EMA’s Committee for Advanced Therapies (CAT) is responsible for providing scientific recommendations on the classification of ATMPs as either gene therapy medicinal products (GTMPs), somatic cell therapy medicinal products (sCTMPs), tissue-engineered products (TEPs),...

Clinical Research: Phase 1 - Phase 4

Premier Study Start-Up: Where a Successful Trial Launch Begins

Industry-wide, spreadsheets have long been the go-to method for tracking clinical trial start-up. Premier Research developed the Premier One Ecosystem to create a paperless, electronic data process, start to finish. Trials begin with our Study Start-Up application, which automates collection of ALL the data related to your trial, then optimizes it to decrease cycle times...

Clinical Research: Phase 1 - Phase 4

LSX 2021: The Path From Preclinical to and Through Clinical

Presented by: Peter Larson, Vice President, Medical Affairs for Hematology-Oncology Angi Robinson, Vice President, Specialty Areas April Marquick, Cell and Gene Therapy Expert Originally presented at the 2021 LSX World Congress virtual conference, this webinar series by Premier experts in oncology, rare disease, and cell and gene therapies focuses on development considerations for advanced therapies,...

Clinical Research: Phase 1 - Phase 4

The Importance of Site Selection and Dosing Strategies in Early-Phase Oncology Studies

Setting up an effective phase one trial for a novel investigational oncology product is rife with challenges. Every aspect from site identification to estimation and coordination of enrollment and safety review is interconnected. Nuance is important. What factors can affect, or even derail, the timeline? Who are the key influencers and experienced sites? Does a...

Data Management & Biostatistics

Establishing Risk-Based Monitoring within a Quality-Based System as ‘Best Practice’ for Clinical Studies

Risk-Based Monitoring (RBM) makes an impact. The US Food and Drug Administration (FDA) requires that clinical trial sponsors “provide oversight to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality of the data submitted to FDA.” [US FDA 2019] This has traditionally been accomplished through onsite monitoring visits and...

Data Management & Biostatistics

Risk-Based Quality Management (RBQM) – A Collaborative Approach to Holistic Clinical Trial Oversight

Developing, executing, and overseeing clinical trials is a complex process. Gaining reliable evidence from clinical trials is essential for appropriate decision-making activities regarding trial participants’ safety and the reliability of trial results.  As clinical trials have become more complex, the clinical trial process has faced significant operational challenges. As a result, sponsors must identify proactive...

Clinical Research: Phase 1 - Phase 4

Considerations In Conducting Pediatric Clinical Trials

There are many challenges inherent in pediatric clinical studies, where the traditional paradigms for evaluating pharmaceutical agents in adults often do not apply. These occur on ethical, physiological, pharmacometrics and economic grounds, among many others. It’s important to recognize that while these efforts are challenging, they are not impossible — and they may be better suited to creative solutions...

Clinical Research: Phase 1 - Phase 4

Untapped Potential: Asia-Pacific’s Growing Role in Biotech Drug Research

Of the 350 million to 400 million people infected with the hepatitis B virus worldwide, one in three lives in China. The country is home to 130 million carriers of the disease and 30 million who are chronically infected.[1][2] Some rural parts of China have an especially high incidence of tuberculosis,[3] and across Asia, prevalence of...

Global Compliance

Data Protection Part 2: Ensuring Study Start-Up Compliance With GDPR

At the beginning of a study, there are a number of steps sponsors and CROs must take to ensure compliance with the EU’s General Data Protection Regulation. In this blogpost, we focus on four GDPR articles that are relevant to study start-up. Article 131 As the data controller, the sponsor must provide a privacy notice...