March 13, 2019

TRiNDS Clinical Operations Services

Clinical trials can be difficult to manage. Trial sites around the world have different local institutional and ethical rules. Central study teams work with multiple different scientific and company stakeholders. Regulations governing clinical trials and drug development require comprehensive and accurate record keeping. And everything needs to be finished on time and on budget.

Rare disease clinical trials present unique management challenges. In rare disease clinical trials, eligible participants are much harder to find and sample sizes are smaller, making each detail of the trial even more critical to its success.

TRiNDS Clinical Operations offers customized trial management to researchers around the world. We assign a lead project manager to your project from the first feasibility assessment to final closeout. Our experts follow established guidelines and procedures to help trials stay on track throughout the course of the project. We’ll work with you to create the plans, strategies, and metrics that your trial will need. We help your team work together effectively for the rapid start up, on target enrollment, regulatory compliance, and accurate data that your research program requires.

TRiNDS offers expert clinical operations support to research studies and clinical trials working with neuromuscular and other rare diseases. Contact TRiNDS today to request a quote.

February 15, 2019

TRiNDS Patient Science Liaison Services

Rare disease clinical trials are not the same as other trials. The paperwork and research rules might be the same, but everything else is different. The tests are different, the providers are different, but most of all, the families are different. People who are coping with a rare disease have different experiences, different fears, and different hopes than people with other kinds of diagnoses.

These differences are at the core of why we do what we do at TRiNDS. We know that conducting clinical trials are both essential to helping people with rare diseases and ask families to add stress to already stressful lives. Helping researchers navigate these issues is a core part of what we do.

TRiNDS Patient Science Liaison services offer customized advocacy, patient outreach, and research education services to researchers working with rare diseases. We can help connect you to the patient groups working in the community and help connect families to your trials. We’ll help you make the materials and strategies that you’ll need to recruit and retain eligible patients to your studies. Do you have an advocacy team? We can help extend your team by attending more events, creating special materials, or answering central inquiries.

TRiNDS offers expert research patient advocacy supports to research studies and clinical trials working with neuromuscular and other rare diseases. Contact TRiNDS today to request a quote.

January 30, 2019

Clinical Research Professionals: Approaches to Informed Consent

The first step of any research study is the informed consent process. Every patient and their family is asked to decide whether or not to enroll in a study through a discussion with site staff and study doctors.

Even though informed consent is important, finding the right balance of enough information at the right time is difficult. Too little information, and the decision isn’t truly informed. Too much information, and the participant becomes overwhelmed. It’s even harder when your participant is a child, or speaks English as a second language, or has limited health literacy.

Researchers at the Michigan Institute for Clinical and Health Research have been working on different ways to make informed consent better. Join the Trial Innovation Network for a webinar on March 20^th. You can learn more by visiting the events page.

TRiNDS offers expert clinical operations support to research studies and clinical trials around the world. Contact TRiNDS today to request a quote.

December 20, 2018

Genetic Disorders in Clinical Trials

We specialize in neuromuscular and rare disease clinical trials. The science is fascinating, but there are a lot more complexities than in other types of clinical trials. Many neuromuscular and other rare diseases have genetic causes, which makes everything even more complicated.

It’s important to design your clinical trial protocols to minimize variability in your study population up front. For many TRiNDS studies, that means confirming participants’ genotypes during study screening. Whether you’re testing an investigational product that acts at the DNA or RNA level, or if you need to exclude certain diagnostic subtypes, having expert help is critical.

We offer central diagnostic confirmation services to research projects and all phases of clinical trials. Our licensed genetic counselors combine their clinical training and research expertise to provide consistent review and analysis of test results. After informed consent, sites or central laboratories submit de – identified reports to our team for review. Our genetic counselors interpret the results and inform the site and the medical monitoring team of the participant’s eligibility for the study.

Contact us to request a quote for central diagnostic confirmation services.

December 5, 2018

Early Bird Registration for the MDA Conference Closes Soon

Even though it’s winter here in the US, spring is just around the corner. In April, clinical providers and researchers will meet for the first combined MDA Clinical and Research Conference in Orlando, Florida. This five day conference is your opportunity to learn from the key opinion leaders caring for children and adults with neuromuscular disorders. You’ll hear about the latest research findings, the best ways to implement great clinical care, and connect with your peers working in the field.

But don’t delay – early bird registration closes at the end of December. Learn more about the conference and register today.