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What are the things that high-performing clinical research sites do that make sponsors return to them again and again?

Each year, approximately 16 percent of patients in United States hospitals are readmitted within 30 days of discharge. Readmissions and the additional treatments they entail are costly to both patients and insurers. Increasingly, they are costly to hospitals as well. A portion of readmissions are considered unavoidable, such as a planned readmission for chemotherapy, or an unexpected adverse event unrelated to the original diagnosis. However, many other readmissions are considered preventable through high quality clinical care and effective patient education and discharge procedures.

Review the need for rater training in clinical trials and review publications that report data on rater characteristics, training modalities and outcomes in terms of accuracy and reliability of clinical outcomes data. 

When you pass a magnet over the surface of ferrofluid, it begins to reach out with its gooey, spikey arms. A team of researchers at Juniata College is using a Phantom high-speed camera to study its unique, magnetic particles that have vast implications for future lab-on-a-chip devices. 

One area coming under increased regulatory scrutiny is change control: the ability to manage deviations to established policies and procedures in a way that is efficient, timely and compliant.

A study needed to enroll approximately 12,000 subjects and was also unique because it required subjects to self-collect samples at home. Read about the risk management and mitigation that Health Decisions utilized to keep the study on track.

A biopharmaceutical company wanted to determine whether patients treated with an oral inhibitor of phosphodieasterase-4 (PDE-4) would show improvement in signs and symptoms of PsA. They used ERT eCOA tablets to collect data about patient symptoms as observed by physicians through the ACR assessment which was used to assess efficacy. Results showed reduced monitoring time and costs, decreased time to database lock, and FDA approval.

There is an increasing need for objectivity in mapping and analyzing of lesions to create confidence in trial findings, reproducibility and translation to clinical practice for dermatology sponsors, regulators and clinicians. This paper examines evolving diagnostic practices coupled with advancing technology and their application to reduce subjectivity in dermatology clinical trials.

A large treatment plant includes several treatment processes that contribute to providing quality recycled water pursuant to the state of California Title 22 regulations. Major treatment processes include raw wastewater pumping, preliminary treatment, primary treatment, secondary treatment, tertiary treatment with Parkson DynaSand® filters, and disinfection.

Today, construction firms are faster to recognize the benefits of innovative technology, says Solibri Product Manager Juan Rodriguez. But the far-reaching nature of Solibri’s users – professionals in multiple disciplines, on every continent – has made it hard to get timely and complete customer feedback. Solibri wanted a much better understanding of how our typical users are engaging with the software through anonymous usage data. If they created a new feature, was it successful? Has it been adopted? Why, or why not?”

Ensuring that studies meet the business goals of sponsors and increase the range of treatment options available to patients and healthcare providers can be challenging when a trial must enroll subjects with a bothersome health condition and ask them to risk randomization to placebo. The project team in a study of an investigational treatment for bacterial vaginosis addressed such challenges and enabled the study to meet the sponsor’s goals.

Regulatory approval of a biosimilar requires comprehensive knowledge of both the process and the molecule while process development with the end goal in mind will help to achieve a robust manufacturing process.