News
–

With the Spring 2018 Update of SimpleCTMS, released last month, the team at Trial By Fire Solutions continues to put our customers first by adding a number of user-driven functionality and scalability enhancements.  This includes easier report authoring for CRAs, more partial payment options, more control over email alerts, and better management of site communications.

Trial By Fire Solutions is pleased to welcome three new clients who have selected SimpleCTMS as their optimal choice for a Clinical Trial Management System (CTMS). SimpleCTMS continues to be selected by a diverse global clientele due to the intuitive and adaptable interface for tracking a comprehensive set of clinical study management needs. Specializing in anti-infective research and development and with operational offices in the United Kingdom, United States, and South Africa, The Micron Group is an international clinical research organization providing full and comprehensive support to their clients, working across all phases of development and throughout the product lifecycle.

SimpleTrials, the latest Clinical Trial Management System (CTMS) from Trial By Fire Solutions, has been recognized as one of the Top 10 eClinical Trial Management Solution Providers for 2017 by Pharma Tech Outlook Magazine. SimpleTrials and Trial By Fire Solutions are featured as the cover story for the Top 10 issue in March 2017.

We’re pleased to announce the latest life sciences client to embrace the power of SimpleCTMS! Our newest client is a clinical stage biopharmaceutical company based in the United States whose focus is developing novel immunotherapies for the treatment of cancer and viral infections. They approached Trial By Fire Solutions after core team members had utilized SimpleCTMS at another company in the past with great success.

Trial By Fire Solutions, the team behind SimpleCTMS, is proud to announce the latest software application in their suite of eclinical solutions for clinical trial management. SimpleTrials revolutionizes CTMS through it’s “on demand” delivery platform. This unique online tool helps small and mid-sized sponsors, CROs and sites move away from worksheet and paper based trackers into a scalable, robust online clinical trial management system that delivers cost effective solutions to virtually any sized organization. 

Trial By Fire Solutions, a leading eClinical solution provider specializing in clinical study management applications, announced today that a public, multi-national, US-based biopharmaceutical company has selected SimpleCTMS to help manage their portfolio of clinical studies for their growing pipeline of drug candidates that target liver diseases.

We are pleased to announce that a clinical stage drug development company based in North Carolina has selected SimpleCTMS to help manage their portfolio of clinical studies for their growing pipeline of drug candidates.

Trial By Fire Solutions, a leading eClinical solution provider specializing in clinical study management applications is now offering validated electronic visit reports (EVRs) as a standard SimpleCTMS offering. Electronic visit report templates for prestudy, initiation, routine monitoring and closeout monitoring visit types, have been functionally validated for immediate client use. Additionally, standard validated functionality includes approval workflows, collaboration tools, electronic signatures, report attachments, and email alerts for the handoff events along the way. Performance reports are available for management trending and oversight of monitor and approver timelines compared to stated monitoring plan requirements.

We’re pleased to announce the recent signing of another commercial stage pharmaceutical company that has selected SimpleCTMS to help them manage the broad number of studies that support their current commercial products and their pipeline of drug candidates in development.The company, based out of the Research Triangle Park area in North Carolina, designs, optimizes and develops novel small molecule drugs involved in rare diseases. Current activities include several ongoing Phase I and II development programs, as well as recent FDA approval of their commercial product for the treatment of influenza.

Trial By Fire Solutions, a leading eClinical solution provider specializing in clinical study management applications, announced today that OPKO Health Inc. has selected SimpleCTMS to help their renal division optimize their clinical program.

The Renal Division of OPKO Health, Inc. is developing proprietary products to treat secondary hyperparathyroidism (SHPT) associated with chronic kidney disease (CKD) and vitamin D insufficiency. These products are designed to safely and effectively treat patients with CKD, but they also have potential application to other indications including metabolic bone disease, such as renal osteodystrophy and osteoporosis. In addition, the Renal Division is developing novel therapies to treat elevated blood phosphorus levels (hyperphosphatemia) in order to improve the control of SHPT in CKD patients.

Trial By Fire Solutions, a leading eClinical solution provider specializing in clinical study management applications, is pleased to announce that ResearchPoint Global, a full service Contract Research Organization (CRO) has selected SimpleCTMS to help manage the clinical study pipelines for their large portfolio of sponsors.

ResearchPoint Global offers a full range of drug, biologic, and device development services for the life sciences industry. In addition to the comprehensive study planning and tracking features, SimpleCTMS will be utilized to integrate and standardize the data from multiple eClinical/EDC systems.  With external data sources used to populate screening, enrollment and visit progress in SimpleCTMS, many other features can be utilized to leverage the full power of SimpleCTMS, such as site payments and dashboards and analytics.  The electronic visit reporting capabilities of SimpleCTMS will also be used to streamline monitoring activities.

Trial By Fire Solutions, a leading eClinical solution provider specializing in clinical study management applications, is pleased to announce that INNO Clinical Outcomes has selected SimpleCTMS to help them optimize and manage a broad range of clinical trials for their life science clients.

Based in Durham, North Carolina, INNO Clinical Outcomes is a full service Clinical Research Outcomes Organization (CROO) that specializes in Phase I-IV clinical trials across multiple therapeutic and geographic areas. They provide a variety of services, including clinical monitoring, biostatistics, pharmacovigilance, and project management.

Trial By Fire Solutions, a leading eClinical solution provider specializing in clinical study management applications, is pleased to announce that their clinical trial management system, SimpleCTMS, has been selected by a leading drug development pharmaceutical company.

The latest SimpleCTMS client is a NASDAQ-listed biopharmaceutical company whose mission is to develop and commercialize life-altering therapeutics. Their lead product received FDA and European Commission approval in 2013. Their clinical development pipeline includes exploring new treatments for neurodegenerative diseases and pediatric conditions. They also have a robust pre-clinical program with novel drug candidates to potentially treat cancers and other diseases. 

We are pleased to announce the latest deployment of SimpleCTMS for bioRASI, a full service global clinical research organization based in Aventura, Florida. A wide variety of life science companies and sponsors count on bioRASI to design, manage and support their clinical trial pipelines. SimpleCTMS will provide bioRASI with an exceptional clinical study management platform as part of their suite of clinical research services offered. 

bioRASI had an urgent need to select and adopt a clinical trial management system (CTMS).  We were able to demonstrate a clear value proposition, a simple pricing model, and then deliver a quick implementation.  We went from initial discussions to system launch and training in about 3 weeks. 

We’re excited to announce that we’ve expanded the user base of SimpleCTMS into the area of academic research organizations. One of the world’s leading academic research organizations has selected SimpleCTMS to facilitate study management activities for their industry sponsored research studies.

The research organization’s adoption of SimpleCTMS will be utilized to streamline critical components of the clinical program where legacy systems and manual trackers have been ineffective.

Despite recent evidence indicating that the overall number of clinical trials in pre-clinical and Phase I-IV have declined in volume, industry research shows that this lack of new study startups may be offset by a growing trend by pharmaceutical and biotechnology companies to outsource their studies and study management to clinical research organizations.

A recent article in PharmaOutsourcing confirms this theory, observing that despite a downturn in the total number of clinical trials in all phases, CROs may still witness a large increase in new clients, as large pharma, biotech and device companies look to keep their costs down.

Trial By Fire Solutions, a leading eClinical solution provider specializing in clinical study management applications, today announced that SimpleCTMS has been selected by a global leader specializing in innovative measurement solutions for the life sciences industry.

The client’s adoption of SimpleCTMS will utilize core study management features of the platform as well as new workflow and tracking features that facilitate the client’s unique study model.  Trial By Fire Solutions has expanded their validated platform services in order to deliver validated Software-as-a-Service (SaaS) in a compliant data center within the client’s aggressive schedule. 

Industry research has indicated that 89% of Sponsors or CROs that manage clinical trials provide clinical research associates (CRAs) and team members with access to a CTMS or other tracking systems. The majority of them combine monitoring tools with a CTMS to achieve greater site monitoring and process efficiency.

Today's trial sites are accepting more diverse studies, constrained by tighter budgets, and under more regulatory compliance scrutiny than ever. As sites track larger amounts of clinical data for their internal monitoring and reporting, clinical teams need flexible tracking tools that give them focused metrics and better validation over their data than paper or spreadsheets can provide.

As 2012 winds down, we are keenly aware that the planning for 2013 studies is very much underway. Whether the New Year entails kicking off fast-paced programs, working with new indications or Sponsors, or simply evaluating progress of current studies, we are confident that our easy-to-use CTMS solution can help you reach your goals in the coming year.

We remain true to our mission of making information sharing easier, study management more streamlined, and providing a flexible and affordable tool to benefit study teams of all shapes and sizes.

Not quite convinced?  Here are some things to keep in mind: