Year: 2019

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 »