SimpleTrials Selected as a Top 10 eClinical Trial Management Solution Provider by Pharma Tech Outlook

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.

Read More

Clinical-Stage Biopharmaceutical Company Quickly Adopts SimpleCTMS For eTMF, EVRs and More

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.

Read More

Trial By Fire Solutions Announce Launch of SimpleTrials Pilot Program

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. 

Read More

Global Biopharmaceutical Company Selects SimpleCTMS

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.

This sponsor organization had previously implemented other eClinical systems including an eTMF and IWRS/EDC systems and were looking for an easy to implement, easy to use CTMS system that could be readily accessed by team members in their global offices. Additionally, they had specific needs to integrate with their EDC provider to facilitate the management of investigator payments related to subject visits.

Read More

Innovative Biotechnology Organization chooses SimpleCTMS

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.

This sponsor organization faced many of the common clinical management challenges, including multi-country studies with outsourced monitoring and essential document tracking.  They needed a system that would be easy to adopt both internally, as well as externally by their vendor teams.  SimpleCTMS provided a compelling suite of functionality to assist with study planning, site startup, enrollment tracking and monitoring.

Read More

SimpleCTMS Provides Validated Electronic Visit Reports ‘Off-the-Shelf’

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.

Read More

SimpleCTMS Selected by Drug Development Pharmaceutical Company

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.
Read More

Multi-National Pharmaceutical Company Selects SimpleCTMS

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.
Read More

SimpleCTMS Selected by ResearchPoint Global for Clinical Study Management

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.
Read More

INNO Clinical Outcomes Chooses SimpleCTMS for Clinical Study Management

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.
Read More

West Coast Pharmaceutical Company Selects SimpleCTMS for Clinical Study 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.
Read More

Global CRO bioRASI Selects SimpleCTMS for Clinical Study Optimization

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.
Read More

Leading University Academic Research Organization Selects SimpleCTMS

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.
Read More

New Opportunities for CROs as Pharma and Biotech Outsourcing Grows

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.
Read More

SimpleCTMS Selected by Fortune 500 Life Science Corporation

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.
Read More

Critical Tasks of Site Monitors: Using a CTMS to Improve Efficiency

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. At the same time, they need a system that is easy to use and doesn't take a lot of time or resources away from the monitoring of clinical research sites.

A web-based CTMS such as SimpleCTMS helps CRAs and support staff:

  • View the status of one or more clinical trials
  • Access subject data and associated tracking records
  • Identify outstanding issues
  • Make informed decisions about requirements for site visits.

Providing CRAs with access to the cross-study and cross-site data available within a web-based CTMS is vital and a key part of site management. There is growing recognition across the industry that when CRAs use a CTMS, they are more efficient in site monitoring and management activities. 

How You Really Can Afford a CTMS Solution in 2013!

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:
Read More

Trial By Fire Solutions Announces New Electronic Visit Reports Functionality in SimpleCTMS

Trial By Fire Solutions, a leading eClinical solution provider specializing in clinical study management applications, today announced the release of SimpleCTMS 3.0. This major release offers a number of new updates and enhancements, including electronic visit reports, improved field customization, and expanded dashboards.
Read More

SimpleCTMS and Projecis Collaborate on Integrated Study Management Solutions for the Life Sciences

Trial By Fire Solutions, a web-based software firm serving the life science industry, has formed a strategic collaboration to integrate Projecis with its SimpleCTMS platform to gain efficiencies in information distribution and knowledge building. The partnership builds on the value that each individual service offering provides to clinical study management.
Read More