March 4, 2020

Clinical Operations in Rare Disease

Managing clinical trials is always complicated. Trial sites are scattered around the world, protocols have complex requirements, and timelines are always tight. Clinical trials in rare disease populations have added complexity due to the nature of the diagnosis and its standard clinical care practices. Eligible rare disease participants are harder to find and are essential to retain. Standard clinical care can be less defined for a rare disease. Complex diseases bring more concomitant medications, more medical history, and more subspecialists to a study.

TRiNDS Clinical Operations offers specialized services for rare neuromuscular disease research. We offer expert project management to leverage our past experiences with the expert sites you’ll need. Our in – house clinical research associates receive specialized training, so they arrive on site for monitoring visits understanding the clinical context of the protocol. Our model is to provide excellent service to our trial sites to support their rapid startup and high-quality data collection throughout the life of the trial.

TRiNDS is a contract research organization (CRO) dedicated to conducting rare and neuromuscular disease research. We are currently accepting new clients developing products for rare disease orphan disease, and neuromuscular patient populations. Contact TRiNDS today to request a quote.

February 19, 2020

Employee Spotlight: Ana Christensen,  Lead Project Manager Strategic Solutions

All of us at the TRiNDS team come to work every day committed to conducting the best quality rare disease and neuromuscular research. Today we’d like to introduce Ana Christensen, Lead Project Manager, Strategic Solutions. We sat down with Ana to learn more about her and her work.

1.  How did you come to work in clinical research?

Ana: I started in clinical research completely by accident. When I was working on my Master’s in Public Health, I thought I would work for a local or state health department. By the time I finished, the available jobs in my area were in clinical research, so I decided to give it a try. I was a site research coordinator for clinical trials and academic research over 12 years in infectious diseases, asthma, medical education, procedural sedation, cerebral palsy, spina bifida, and Duchenne muscular dystrophy. I think clinical research is a powerful way to answer important questions that support better clinical care, better treatments for patients, and better outcomes for families living with chronic illness.

2.  What does your typical day look like at TRiNDS?

Ana: I support TRiNDS’ Strategic Solutions – our set of unique services that help clients navigate the unique needs of rare neuromuscular drug development. One of my main roles is to help clients engage with the communities they hope to serve. You’re likely to meet me at US community events and conferences, helping families to understand clinical trials. When I’m not travelling, I manage client projects that use Strategic Solutions – everything from our network of Clinical Evaluations Managers to our standing Data Safety Monitoring Board.

3. What are you most excited about for the future of neuromuscular research?

Ana: I am inspired by the hope for better treatments for people with neuromuscular disorders. When I started coordinating clinical trials for Duchenne muscular dystrophy, there was only one trial available. Now, there is an entire pipeline of investigational drugs and treatments being studied by companies and researchers around the world.

February 5, 2020

Planning for Genetic Variability

At TRiNDS, we focus on the unique needs for companies conducting clinical trials in rare disease populations. Clinical trials are always challenging, but rare neuromuscular disorders add complexity to study design and execution.

Many neuromuscular disorders have genetic causes, such as spinal muscular atrophy (SMA) and Duchenne muscular dystrophy (DMD). Unlike other disorders, an individual’s diagnostic genotype can vary widely, affecting the severity of symptoms, standards of clinical care, and natural history of disease progression.

It is important to design your clinical trial protocols to minimize variability in your study population. For many 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 you’re excluding certain diagnostic subtypes, having expert help is critical.

TRiNDS offers 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 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.

January 16, 2020

Employee Spotlight: Caroline Bong, Clinical Research Intern

All of us at the TRiNDS team come to work every day committed to conducting the best quality rare disease and neuromuscular research.  Today we’d like to introduce Caroline Bong, Clinical Research Intern. We sat down with Caroline to learn more about her and her work.

How did you come to work in clinical research? 

Caroline: Prior to and during my genetic counseling graduate school career, I have had incredible opportunities to help those affected by a genetic condition through clinical settings. As equally impactful to those affected individuals is the work being done slightly more behind the scenes in the research realm of genetic diseases. With much less experience in clinical research, it was very important to me to gain exposure and contribute to this particular side of genetics, which ultimately led me to my work in clinical research at TRiNDS.

What does your typical day look like at TRiNDS?

Caroline: As a clinical research intern, my typical day TRiNDS focuses on supporting the project managers for the various clinical trials. This consists of managing the study files, running an assortment of reports, and working predominately within TRiNDS’ electronic trial master files (eTMFs) to help oversee our clinical research sites.

What are you most excited about for the future of neuromuscular research?

Caroline: I am most excited for the potential of gene therapies to not only treat neuromuscular conditions, but to possibly cure them. Making this treatment a reality and increasing the availability of the therapy in a financial sense would be momentous for affected individuals, their families, and the genetics community as a whole.

Caroline is working on a research project for her master’s thesis about women who are DMD carriers. She is seeking women who are DMD carriers and are over the age of 18 to participate in a survey about their reproductive decisions.  If interested, you can complete the survey here: https://bit.ly/35Ztx2F

TRiNDS offers expert custom services to sponsors conducting clinical trials throughout the development process. We customize expert services to each project to meet its unique needs. Contact us for more about how TRiNDS can help your project succeed.

January 8, 2020

Expert Neuromuscular Research Support

TRiNDS offers a unique contract research organization (CRO) service model to clients conducting research and drug development for rare and neuromuscular disorders. Drug developers and researchers often can’t do everything in – house for every project – it’s too difficult to build the capacity needed to run, supervise, and analyze everything involved in a clinical trial. That’s where a CRO comes in – a company who provides needed services for a research project. A CRO can provide everything from trial master file management, to ethics approvals support, to database management, and everything in between.

TRiNDS is a CRO offering a higher level of expertise for neuromuscular and rare disease research. Our teams have extensive experience and specialized training for conducting clinical research with neuromuscular and rare disease populations. We maintain deep connections with subject matter experts publishing innovative work in the field. We work with productive and committed sites around the world. We work with the unique contexts and needs of rare disease research every day. It’s what we do.

What does that mean for your project? It means that your assigned TRiNDS team will help you select services and build study systems to match your project and your population. We’ll help you set up your trial to maximize efficiency, to plan for the expected data from your population, to find and train the best sites, and to stay on time and on budget. We come to work each day committed to rare disease research, and ready to leverage our experience for our clients.

TRiNDS offers expert custom services to sponsors conducting clinical trials throughout the development process. We customize expert services to each project to meet its unique needs. Contact us for more about how TRiNDS can help your project succeed.

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.