Author: Terri Fettinger

Specialized Services for Neuromuscular Research

December 2, 2020 Specialized Services for Neuromuscular Research TRiNDS is a contract research organization (CRO) providing specialized services to companies and researchers working with rare neuromuscular disorders. TRiNDS is a full service CRO offering the solutions needed for clinical trials – everything from trial master file management, to ethics approvals support, to database management, and… Read more »

TRiNDS Team Spotlight: Erica Butler, Clinical Research Associate

November 18, 2020 TRiNDS Team Spotlight:  Erica Butler, Clinical Research Associate All of us at TRiNDS come to work every day committed to conducting the best quality rare disease and neuromuscular research. Today we’d like to introduce Erica Butler, Clinical Research Associate. We sat down with Erica to learn more about her and her work…. Read more »

TRiNDS Genetic Confirmation Services

November 11, 2020 TRiNDS Genetic Confirmation Services Many of the rare neuromuscular disorders we work with at TRiNDS have a genetic component. Some are caused by a variation in a gene or group of genes and others can be assigned subtypes by presence of certain variations. For a rare neuromuscular clinical trial, it’s essential to… Read more »

TRiNDS Team Spotlight:  Linda Johnson, Clinical Evaluations Manager

October 21, 2020 TRiNDS Team Spotlight:  Linda Johnson, Clinical Evaluations Manager All of us at TRiNDS come to work every day committed to conducting the best quality rare disease and neuromuscular research. Today we’d like to introduce Linda Johnson, Clinical Evaluations Manager. We sat down with Linda to learn more about her and her work…. Read more »

WMS 25 Challenge

October 14, 2020 WMS 25 Challenge All of us at TRiNDS are dedicated to supporting innovative clinical research for people with neuromuscular disorders. This year, the World Muscle Society had its first ever virtual congress and celebrated its 25th year. To mark the occasion, attendees from around the world participated in fundraising activities for neuromuscular… Read more »

TRiNDS Data Management Services

October 7, 2020 TRiNDS Data Management Services Every clinical trial or research study collects data to answer scientific questions. How the data is collected, cleaned, and coded impacts its research utility. In rare disease studies, sample sizes are smaller, and each data point is critical. Data from rare disease populations can be hard to plan… Read more »

Employee Spotlight: Andrea D’Alessandro, TRiNDS Director of Clinical Operations

September 2nd, 2020 Employee Spotlight:  Andrea D’Alessandro, TRiNDS Director of Clinical Operations All of us at TRiNDS come to work every day committed to conducting the best quality rare disease and neuromuscular research. Today we’d like to introduce Andrea D’Alessandro, TRiNDS Director of Clinical Operations. We sat down with Andrea to learn more about her… Read more »

Measuring Clinical Outcomes

August 5, 2020 Measuring Clinical Outcomes In most studies, it’s easy to know when an investigational drug or device is effective. You can count tumor cells in a sample, families can report the number of symptom free days, or you can count how many times a patient used a rescue medication. In rare neuromuscular disorders,… Read more »

Employee Spotlight:  Suhasini Sheela, TRiNDS Data Manager

July 14, 2020 Employee Spotlight:  Suhasini Sheela, TRiNDS Data Manager All of us at TRiNDS come to work every day committed to conducting the best quality rare disease and neuromuscular research. Today we’d like to introduce Suhasini Sheela, Data Manager in TRiNDS Data Management. We sat down with Suhasini to learn more about her and… Read more »

Handling the Unexpected

  July 8, 2020 Handling the Unexpected TRiNDS Clinical Operations specializes in managing clinical trials in rare neuromuscular disorders. As with other types of trials, our work is often centered around making study plans, managing timelines, and creating contingency plans for expected problems. Neuromuscular disorders themselves add an additional layer of uncertainty to our work…. Read more »

TRiNDS Team Spotlight: Lauren Morgenroth, TRiNDS Chief Executive Officer

June 25, 2020 TRiNDS Team Spotlight:  Lauren Morgenroth, TRiNDS Chief Executive Officer All of us at TRiNDS come to work every day committed to conducting the best quality rare disease and neuromuscular research. Today we’d like to introduce Lauren Morgenroth, TRiNDS Chief Executive Officer. We sat down with Lauren to learn more about her and… Read more »

Supporting Clinical Trial Sites: Genetic Confirmation Services

June 3, 2020 After many years of exciting preclinical developments, many companies are now bringing investigational products for rare neuromuscular disorders to clinical trials. Clinical trials about rare neuromuscular disorders are more challenging than more common diseases, in part due to how these disorders are diagnosed. Many rare neuromuscular disorders have genetic causes, such as… Read more »

Employee Spotlight: Maya Shimony

May 13, 2020 Employee Spotlight:  Maya Shimony, Lead Data Manager, TRiNDS Data Management 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 Maya Shimony, Lead Data Manager in TRiNDS Data Management. We sat down with Maya… Read more »

Italfarmaco: Updates on Givinostat for Duchenne Muscular Dystrophy

April 27, 2020 TRiNDS is honored to work with clients from around the world working to develop investigational products for rare neuromuscular diseases. Today, one of our clients shared a press release about their progress. Italfarmaco Group has issued a press release (link: https://www.businesswire.com/news/home/20200427005274/en/Italfarmaco-Update-Advanced-Stage-Clinical-Development-Program-Givinostat) to provide an update on the clinical development program with Givinostat… Read more »

We Put the Pieces Togeter for Your Project

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… Read more »

Employee Spotlight – Ana Christensen

February 19, 2020 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… Read more »

Planning for Genetic Variability

February 5, 2020 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… Read more »

Employee Spotlight: Caroline Bong, Clinical Research Intern

January 16, 2020 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… Read more »

Expert Neuromuscular Research Support

January 8, 2020 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… Read more »

TRiNDS Data Management Services

December 4, 2019 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… Read more »

Apply to Join the TRiNDS Team Today!

  October 30, 2019 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… Read more »

Dedicated to Rare Disease

September 11, 2019 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… Read more »

Continuing Education Opportunity

August 28, 2019 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… Read more »

TRiNDS Patient Science Liaison Services

August 14, 2019 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… Read more »

Cultivating Excellence at Work: TRiNDS Continuing Education

July 26, 2019 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…. Read more »

TRiNDS Data Management Services

July 10, 2019 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… Read more »

Happy Summer from TRiNDS!

July 3, 2019 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… Read more »

FDA Draft Guidance: Increasing Diversity in Clinical Trials

June 26, 2019 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… Read more »

FDA Draft Guidance: ANCOVA in Randomized Clinical Trials

  May 23, 2019 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… Read more »

TRiNDS Annual Meeting

May 8, 2019 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… Read more »

TRiNDS is Hiring

March 20, 2019 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…. Read more »

Stay on Course

March 13, 2019 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… Read more »

TRiNDS Celebrates Rare Disease Day 2019

February 27, 2019 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… Read more »

TRiNDS Patient Science Liaison Services

February 15, 2019 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,… Read more »

Clinical Research Professionals: Approaches to Informed Consent

January 30, 2019 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… Read more »

Genetic Disorders in Clinical Trials

December 20, 2018 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… Read more »

Early Bird Registration for the MDA Conference Closes Soon

December 5, 2018 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… Read more »

Frequently Asked Questions: How do You Work with Clients?

November 14, 2018 TRiNDS is a specialized neuromuscular contract research organization offering expert level support for clinical trials, post marketing studies, and academic research. Our clients are biopharmaceutical companies working to develop new treatments for neuromuscular disorders around the world. Our approach is to work in partnership with our clients to meet project goals without… Read more »

New Supplements: Duchenne Muscular Dystrophy Care Guidelines

November 9, 2018 The October 2018 issue of Pediatrics included a set of critical documents for the good care of children with Duchenne Muscular Dystrophy (DMD). The special supplement included a series of 12 articles outlining best practices for multidisciplinary management of DMD. These articles build on the 3-part Lancet overview articles published in January…. Read more »

Happy Fall from the TRiNDS Team!

October 31, 2018 Last week, TRiNDS staff travelled to beautiful Central Pennsylvania from all over the country for our annual retreat. We spent two days together to review our company progress, update our annual training, and to plan for the future. We did take some time for play – everyone enjoyed a visit at a… Read more »

FDA Invites Public Comment On Adaptive Designs

October 25, 2018 The Food and Drug Administration (FDA) released an updated draft guidance to industry in early October entitled, “Adaptive Designs for Clinical Trials of Drugs and Biologics: Guidance for Industry.” The draft guidance reviews best practices for trial design, analysis, and reporting of clinical trials using different adaptive design strategies. The public is… Read more »

Newborn Screening Update for Duchenne Muscular Dystrophy

October 18, 2018 The Duchenne muscular dystrophy (DMD) community took two big steps toward newborn screening this month. Newborn screening programs are important because they allow early diagnosis even before symptoms are observed. Newborn screening facilitates early treatment and rapid development of new therapies for infants everywhere. When infants are born in the United States,… Read more »

Success at WMS

October 10, 2018 World Muscle Society was a great success for TRiNDS, CINRG, and TRiNDS’ clients and collaborators. In addition to three days of presentations, researchers presented over 175 posters in a poster session. Poster presentations shared results from all different types of research and clinical trials about all different types of neuromuscular disorders. We… Read more »

Building Your Team: Becker Muscular Dystrophy

October 3, 2018 Next week is Becker Muscular Dystrophy (BMD) Awareness Week, a time for everyone to recognize the families around the world living with BMD. BMD affects 1 in 35,000 males worldwide. People with BMD show symptoms of muscle weakness in the teen years and can often keep walking into adulthood. Even though good… Read more »