Online Extras

Advances in our understanding of the genetic, immunological, and environmental factors that contribute to the pathogenesis of psoriasis have led to the development of very effective precision therapies that alleviate patient morbidity and improve quality of life, especially for patients with moderate to severe disease.

The results of a 2018 survey of sponsor, CRO, and technology companies.

Cell and gene therapies are the latest wave of advanced technologies that will shape the face of the modern-day biopharma arena, enabling a path to pinpoint a faulty gene or cellular mechanism at the root of a specific disease.

uMotif worked with IDEO to shape a patient-centric approach by focusing on human-centered design.

A new RBM method used in PaxVax trial proves successful vs. onsite source data verification for trial oversight.

This article will detail how the Amarex Safety & Pharmacovigilance team performs medical coding using an internally developed safety platform.

These seven key building blocks for success are outlined to help companies develop and implement a data-and-analytics-driven approach to clinical trial feasibility.

A reduction of Clinical Trial Agreement Review times has caused rapid development in Malaysian clinical trials.

This article will focus on a case study example of a collaborative effort to share investigator, site, and study information across companies, and on the single data model that underpins it.

Data integrity is the essence of GMP, the cornerstone of how the industry operates, and it is vital that all organizations embrace it to survive the rapidly changing life sciences landscape.

In this study, Clinical Trials Transformation Initiative’s database for aggregate analysis of ClinicalTrials.gov was used to evaluate the number of ongoing and completed interventional clinical trials for various coronary diseases.

The emergence of CTiD offers the potential to remove future clinical failures much earlier in the process-and pave way for gains in R&D productivity.

Industry experts look at how the specific needs of patients come into play when conducting gene-based screenings.

How the use of M&S in cancer trials from the outset can help address those critical “what if?” scenarios and accelerate oncology drug development.

The region is significantly underrepresented in clinical development activity targeting childhood cancer.

Insights on the challenges, activity, and motives in merging bridging research and clinical care.

This article will address concerns and look at how the pragmatic implementation of surveys in today’s clinical trials can provide valuable insight into patient satisfaction levels, motivators, likelihood to follow study requirements and information retention.

AMPLEXOR’s Dana Weiss explains the critical role of linguistic validation in enabling the patients voice.

Machine learning algorithms can be used to both manage the complex outputs in clinical trials and make those trials move faster with less risk, reducing timelines, and minimizing expenses.

This article will examine the ways to detect fraud and data fabrication within a clinical trial.

Looking beyond the hype to see how innovations such as data, techniques, and technology can be brought together to improve the lives of patients.

The potential for innovative gene therapies to treat and even cure a range of serious diseases is prompting FDA to ramp up support for developing and testing new products efficiently and effectively.

Companies can utilize the following five tools to set themselves up for a successful trial.

As international outsourcing continues to drive the parties contributing to clinical trials farther apart, technology will increasingly serve as a means of bringing them closer together.

From 2019, to comply with requirements for greater transparency around clinical research as part of the EU Clinical Trials Regulation 536/2014, life sciences firms will be expected to prepare plain-language summaries for all Phase I through IV interventional trials, which can be understood by patients, the general public, and experts.

When less is more. Using three referral labs vs. one central lab.

A discussion of the cost and time put into clinical trials.

Adoption of the concept of Risk-Based Budgeting could help maintain the trial budget or even save the whole clinical trial.

The adoption of automated payment methods for phase I trials will allow for more effective clinical trials.

Despite the evidence that the Hispanic population is increasing at a formidable rate, they not only face disadvantages in health care access, but are significantly underrepresented as participants in biomedical research.