December 4, 2019

TRiNDS Data Management Services

While data is at the center of every research project, data management strategy and implementation can seem mysterious. Data management is more than just issuing queries and locking case report forms – it includes all the steps and systems that you’ll need to prevent user error, flag problems for rapid response, and prepare datasets for analysis. In rare disease trials, data management is essential to utilize every data point from a limited number of participants.

TRiNDS Data Management offers comprehensive and customized data management services to neuromuscular rare disease trials. A lead data manager first helps you choose the right systems and processes for your specific project. The data manager will create case report forms, electronic data capture systems, automatic validation processes, quality control, and data imports and exports. Our data management team leverages their extensive experience and training to help you plan for the data expected for your patient population.

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.

October 30, 2019

Apply to Join the TRiNDS Team Today!

TRiNDS has two job postings open at https://trinds.com/about-us/careers/. We are looking for a Clinical Research Data Manager to join the Data Management team to handle data for critical clinical trials and research studies for people living with rare diseases. We are also seeking a Clinical Research Project Manager to join the Clinical Operations team. The Clinical Operations team works with clients to manage clinical trials and research studies at sites around the world.

TRiNDS is a great place to work and grow. Our expert teams specialize in neuromuscular and rare disease 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. We offer competitive benefits and collaborative company culture.

Are you interested in joining the team? Do you know the perfect people for these positions? Apply today here. We look forward to hearing from you!

September 11, 2019

Dedicated to Rare Disease

TRiNDS is a neuromuscular and rare disease contract research organization (CRO). That means that our staffing, processes, and systems are designed with the unique needs of people with neuromuscular disorders and other rare diseases in mind.

We know rare and orphan disease clinical trials face different struggles than those about more common diagnoses. It’s harder to find eligible participants, the clinical care is more complex, the timelines are tighter, and the outcome measures are harder to execute.

All of us at TRiNDS come to work every day dedicated to making the best possible rare disease and neuromuscular clinical trials for people around the world. Whether it’s making clean datasets, hitting project management milestones, or running quality control checks on the eTMF – everyone works with our population in mind.

Our company was created in response to the needs of the neuromuscular and Duchenne muscular dystrophy (DMD) community. As Duchenne Awareness Month activities begin, it’s a time to reflect on where we’ve come from and where we’re going. The world of DMD drug development has rapidly changed the options for families everywhere. In other ways, DMD and neuromuscular drug development is just getting started – everyone will need to work together and stay focused in the months and years to come.

TRiNDS is a rare disease and neuromuscular CRO focused on executing high quality clinical trials in partnership with the community and innovative sponsors. As a specialty CRO, we help our clients to manage the unique needs of rare disease patients to complete clinical trials on time and on budget. Our rare disease focus and neuromuscular origins helps us to provide expert services for clinical operation, data management, and more. TRiNDS is currently accepting new clients developing products for rare disease, orphan disease, and neuromuscular patient populations. Contact TRiNDS today to request a quote.

August 28, 2019

Continuing Education Opportunity

Before you can launch your new product for a rare disease, you need results from a clinical trial. Before you have your results, you need to fully enroll rare disease patients into the trial. Patients have more choices than ever before for participation in neuromuscular clinical trials. A common barrier to rapid enrollment is using language too complex for eligible patients to understand. The Trial Innovation Network is hosting a webinar on October 7^th where you can learn the latest strategies to incorporate health literacy principles into your clinical trials.

TRiNDS is a contract research organization (CRO) focused on executing the best rare disease and neuromuscular clinical trials in partnership with the community. As a neuromuscular CRO, we help our clients understand the contexts of eligible patients and their families to speed recruitment and to complete trials on time and on budget. Our rare disease focus helps us to provide expert services for clinical operation, data management, and more. TRiNDS is currently accepting new clients developing products for rare disease, orphan disease, and neuromuscular patient populations. Contact TRiNDS today to request a quote.

August 14, 2019

TRiNDS Patient Science Liaison Services

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.

July 26, 2019

Cultivating Excellence at Work: TRiNDS Continuing Education

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.

July 10, 2019

TRiNDS Data Management Services

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.

July 3, 2019

Happy Summer from TRiNDS!

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.

June 26, 2019

FDA Draft Guidance: Increasing Diversity in Clinical Trials

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.

May 23, 2019

FDA Draft Guidance: ANCOVA in Randomized Clinical Trials

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 24^th.

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.