Rare disease clinical drug development is stronger than ever – new mechanisms of action are being explored, breakthrough technology is getting ready to reach the clinic, and families are feeling more hopeful than ever for new therapies that could improve the quality of their lives. Clinical trials with rare disease populations are difficult for companies and researchers to navigate. In addition to the typical rules and regulations surrounding clinical development, rare disease clinical trials must address families’ needs and expectations in busy areas of drug development. Families are asked to choose between multiple trials based on complex science and intensive trial schedules. People coping with rare diseases have different experiences, fears, and hopes than people with more common diagnoses.
These differences are the core of our work at TRiNDS. We know that conducting clinical trials are essential to helping people with rare diseases but ask families to add stress to very stressful lives. Helping researchers and companies 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 and companies working with rare disease populations. 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.
TRiNDS is a unique partner in rare disease research in part due to our culture of excellence. We assemble expert teams who bring their specialized knowledge and experience to every project, every day. We foster collaboration, providing the highest level of service using the most current methods and approaches in our field. One of the ways we cultivate our commitment to excellent service is our staff continuing education program. TRiNDS supports every employee to attend continuing education conferences or trainings once a year. This year, members of our team will attend the Society of Clinical Research Associates (SOCRA) conference, the Society for Clinical Data Management (SCDM) conference, the National Conference on Health Communication, Marketing, and Media, and many others. Everyone returns reenergized with new information, recommitted to the work at hand, and ready for another year of supporting innovation in clinical research.
TRiNDS offers expert research and clinical trial services to sponsors and researchers around the world. We customize our services to each project and its goals. Contact us today to learn how TRiNDS can help your project find success.
Every research project and every clinical trial need high quality, consistent, and accurate data to succeed. Without reliable data, it’s impossible to answer the critical scientific questions or to demonstrate an investigational product’s efficacy and safety. In rare disease trials, understanding which data points are correct and which are unexpected is not a simple process. Rare diseases can routinely generate testing results that would be completely out of range for other populations.
TRiNDS Data Management offers comprehensive and customized data management services to researchers around the world. We first assign a lead data manager to your project to help you plan for case report forms, electronic data capture, automatic validation processes, quality control, and data exports. Our data management team leverages their extensive experience and training to help you plan the data expected for the diagnoses in your trial. Our team works with you to find the right approach to collecting and validating the data you need to answer your scientific questions.
TRiNDS offers expert data management services to sponsors conducting clinical trials throughout the development process. We customize services to each project to meet its unique needs. Contact us for more about how TRiNDS can help your project succeed.
All of us at TRiNDS would like to wish you and your family a safe and fun summer season. Stay tuned to hear updates over the next few months about the work we’re doing to support innovation for neuromuscular and rare diseases.
Contact us to learn more about how TRiNDS supports clients find research success.
The Food and Drug Administration (FDA) recently released a new draft guidance entitled, “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry.” As with other clinical trials, inclusion and exclusion criteria in rare disease trials limit who can participate for safety, analysis, or other reasons. Sponsors and researchers struggle with the balance between increasing the chance of detecting real effects of the investigational product an limiting the generalizability of the trial findings. In this new guidance, the FDA recommends that sponsors consider removing inclusion criteria in later phase trials, using enrichment strategies, and increasing supports offered to trial participants. You can read the draft guidance here and enter your comments before August 30th.
TRiNDS offers expert clinical trial services to sponsors conducting clinical trials throughout the development process. We customize services to each project to meet its unique needs. Contact us for more about how TRiNDS can help your project succeed.
The Food and Drug Administration (FDA) has recently released
a new draft guidance entitled, “Adjusting for Covariates in Randomized Clinical
Trials for Drugs and Biologics with Continuous Outcomes – Guidance for
Industry.” This document would build on the ICH guidance for industry, “E9
Statistical Principles for Clinical Trials” by specifying the appropriate uses
of analysis of covariance (ANCOVA) in randomized clinical trials. The draft
guidance is open for public comment until June 24th.
Clinical trials testing investigational drugs and biologics
in rare disease populations are more difficult than in more common diseases.
Rare disease trials must be successful despite smaller sample sizes of patients
who may have had varying disease severity, routine clinical care, and impact on
quality of life prior to enrollment in the trial. Industry sponsors struggle to
balance increasing diversity of trial participants while maximizing a trial’s
statistical power. This new draft guidance includes recommendations for using
ANCOVA to increase power without increasing statistical error.
TRiNDS offers expert data management and biostatistical support to rare disease clinical trials and research studies. Are you struggling with the analysis plans for your study? Contact us to request a quote today.
TRiNDS is dedicated to clinical trials and research for
people with neuromuscular and other rare diseases. Rare disease research is
evolving quickly – the science is complex, the populations are small, and
everyone wants to finish trials quickly. It takes a team of experts to reach
rare disease research goals.
TRiNDS is guided by an expert board of advocacy group
leaders, researchers, and clinicians who help us do our best work for our
clients. The experts on our board bring perspectives from industry, academia,
major clinical centers, and non – profit groups. We rely on them to help steer
our work in the right direction. This
week, our teams are travelling to the main TRiNDS offices for our annual
company – wide meeting. We’ll be taking time to reconnect, to reflect on our
accomplishments, and to plan for the year ahead.
Are you starting a rare disease research project in 2019? Email us to learn how our unique business model can support your projects’ success.
TRiNDS has two job postings open in two cities at TRiNDS Careers. In Washington, DC we are looking for a contract Clinical Data Manager to join our data management team. The second opening is for an in-house Clinical Research Associate to work in our Pittsburgh, PA office with our clinical operations team.
TRiNDS is a great place to work and grow. Our expert teams specialize in neuromuscular research and clinical trials conducted around the world. We collaborate with innovative clients, expert researchers, and key opinion leaders to generate research success that matters to families affected by rare diseases.
Are you interested in joining the team? Do you know the perfect person for these positions? Apply today at the link above. We look forward to hearing from you!
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.
Every year, on the last day of February, the world celebrates Rare Disease Day. One day a year, we honor the patients and families living with a rare disease around the world. Rare diseases affect 1 in 20 people at some point in their lifetime.
Even though there are many different rare diseases, everyone faces the same kinds of struggles. A lack of awareness and scientific knowledge delays diagnosis. Lack of funding for research slows development of effective treatments. Families struggle to access high quality health care where they live.
All of us at TRiNDS are so grateful to work with scientists, families, and community groups to help find new approaches to rare diseases around the world. Join us in celebrating Rare Disease Day by visiting www.rarediseaseday.org to learn more.
TRiNDS offers customized services for rare disease clinical trials and research studies. We work with companies large and small to find research success. Contact us today to request a quote for your project.