Category: Company Updates

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The Importance of Selecting the Right Clinical Trial Sites

Posted on by Mark Haft

Before a potential new treatment can reach patients, it goes through several clinical trial phases that test the treatment for both safety and effectiveness. This process can be long and costly. Together, clinical trial phases take six to seven years on average. The average cost to research and develop each successful drug is estimated to be $2.6 billion. The importance of selecting the right clinical trial Site and Site feasibility within clinical trials is essential to accelerate the clinical trial process overall. Financial resources and time are at stake in the clinical trial Site selection process. Today, LINEA System, LLC will be discussing Site Identification, the importance of selecting the right clinical trial Site, and a solution that optimizes the Site identification process. 

What is Site Identification & Feasibility?

Within the clinical trial set-up process and trial planning, two crucial components are Site identification and feasibility. The tasks associated with Site identification, feasibility, and activation intertwine into the clinical trial protocol which is developed before Site identification can take place. Site ID is the process of selecting the right clinical trial Site to handle the trial. In addition, Site feasibility evaluates the selected Site to ensure the Site has the proper resources and facilities to ensure the clinical trial will develop effectively to accomplish the objectives set.

Importance of Selecting the Right Clinical Trial Sites

When going through the trial planning process many may wonder about the significance of Site identification and feasibility. A multitude of steps, such as research on patients and Site data are involved which makes the process tedious. However, the significance of Site identification is crucial as it can save ample time and financial resources.

Identifying quality investigative Sites is essential as it fuels optimal patient recruitment. Specifically, patient recruitment that can be done within the time frame required and with the correct patients that can participate in the trial. Selecting the right clinical trial Site fuels patient recruitment and the quality of the trial and the data obtained ultimately. Patient recruitment is so crucial to trials as it can affect the entire trial. To put into perspective, approximately 80% of clinical trials are delayed or closed because of problems with recruitment.

If the Site identification process is done poorly it can hurt the sponsor’s resources and the overall quality of the trial. Here are some other statistics to stress the importance of quality Site ID: 9 out of 10 trials require the original timeline to be doubled in order to meet enrollment goals; 11% of research Sites fail to enroll a single patient; Delays can cost sponsors between $600,000 and $8 million in opportunity cost for each day that a trial delays a product’s development and launch.

How to Select the Right Clinical Trial Sites: AcceleTrial®

Now that we have discussed Site identification and the significance of selecting the right clinical trial Sites, how can you select the proper Sites? To choose the proper clinical trial Sites you can utilize a study start-up system (SSUS) like AcceleTrial®.  AcceleTrial® takes the guesswork out of clinical trial Site identification and activation. Our Study Start-Up System is based on the foundation of objective Site data rather than self-identification.  AcceleTrial®, enables sponsors to streamline and automate the study start-up process to reduce the time it takes to launch clinical trials and patient recruitment. When a sponsor identifies the right investigators and clinical study Site first, the trial begins faster and critical medicine gets to patients who need it most.

The AcceleTrial® platform, in combination with LINEA System’s proprietary algorithms, allows LINEA System’s clients to quickly access, extract, organize, index, and integrate critical data on over 300,000+ clinical investigator Sites. The database allows Sponsors to access specialized data without having to spend extensive time researching such information. The Study Start-Up System has an automated workflow that allows sponsors to save time and resources and allocate such to other priorities. With such a database, a Sponsor can reap the benefits of selecting the right clinical trial Sites through an accessible system making the process efficient and effective. We believe AcceleTrial® can make an industry wide impact on the clinical trial process, accelerate the rate of bringing new medicines to market, and find the right Sites using objective data. 

Now that you have the knowledge and tools to select the right clinical trial Sites the Site ID process can be done with ease.

This post was all about the importance of selecting the right clinical trial Sites. 

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jobcreatorsquestgrant

LINEA System, LLC Finishes Founder’s First Bootcamp & is Prepared for Large Scale Growth

Posted on by Mark Haft

Back in September of 2021, LINEA System LLC, a leader in accelerating clinical trial study start-up, announced that it had been awarded the Founders First Job Creators Quest Grant in Pennsylvania/New Jersey. The Grant consisted of a monetary award as well as a full-tuition scholarship to Founders First’s Bootcamp accelerator program exclusively for diverse founders. The Bootcamp finished in April and culminated with a pitch competition.

Learn more about our collaboration with Founders First and the Job Creators Quest Grant. Discover how it has impacted the development and growth of LINEA’s mission to accelerate clinical study start-up.

The Impact of the Job Creators Grant on LINEA System, LLC

The impact of the Job Creators Grant on LINEA has been astonishing. We have been able to prioritize expansion. Our team has grown and the resources of the LINEA team has expanded to further develop the company and the mission to revolutionize clinical trials. As Kathleen Colatrella, CEO and Founder of LINEA System reported with Founders First,

“The job creators grant through Founders First has helped us significantly. We were able to actually bring some new sales reps onto the team and put those funds toward training to equip them with the information and the tools that they need to be able to continually get the word out for the awareness of our program and our software.”

Not only has the Job Creators Grant provided a pillar to develop our mission financially but also through knowledge. The program provided us a voice and resource to further express our intentions and objectives. Since the program has ended, LINEA has experienced growth and a firmer foundation. As Colatrella stated to Founders First,

“We were able to pitch clearly our intentions and projections to three different investment companies and we’ve been invited for a second round for two out of three.

We’re looking to secure funds, and I think that Founders First prepared us well to be very clear on what is that we are offering, what is the opportunity for any investor and then how they can partner with us to make this company grow.”

For the full article on the collaboration between Founders First and LINEA System Click Here:

https://foundersfirstcdc.org/kathleen-colatrella/

About LINEA System, LLC

LINEA System, LLC is a leader in accelerating clinical trials by leveraging data and technology in a completely new way. The company specializes in site identification, feasibility assessment, and site activation. LINEA System’s cloud-based Study Start-up System (SSUS), AcceleTrial™, enables teams to streamline and automate the study start-up process to drastically reduce the launch time of clinical trials and accelerate patient recruitment.

About Founders First CDC

Founders First is a community development organization and micro-small business accelerator assisting under-served and under-represented established small businesses. The organization focuses on accelerating the growth of diverse-led businesses. The programs provided guide business owners through the process of achieving accelerated growth through specific tasks and expert coaching. An emphasis is placed on service-based businesses led by women, ethnic minorities, military veterans, and businesses located in low to moderate-income areas.

This post was all about the Job Creators Quest Grant

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LINEA System is Officially Certified as a Minority/Woman-Owned Business Enterprise

Posted on by Sarah Hof

PARSIPPANY, NJ — LINEA System, a leader in accelerating clinical study start-up, announced today that it has been certified as a Minority/Women-Owned Business Enterprise (MWBE) by the State of New Jersey. 

“Earning our Minority/Women-Owned Business Enterprise certification is representative of the values and standards we hold ourselves to, and of those to which we hold vendors and partners.” says Leticia Bidó, VP, Client Success & Strategic Operations at LINEA System. “We are excited to be able to strengthen the supply chain and open up new opportunities with clients who are committed to supporting supplier diversity.”

LINEA System, and businesses from all industries who have been certified, can be found on the New Jersey Selective Assistance Vendor Information (NJSAVI) database by searching here. 

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About LINEA System, LLC

LINEA System, LLC is a leader in accelerating clinical trials by leveraging data and technology in a completely new way. The company specializes in site identification, feasibility assessment, and site activation. LINEA System’s cloud-based Study Start-up System (SSUS), AcceleTrial™, enables teams to streamline and automate the study start-up process to drastically reduce the launch time of clinical trials and accelerate patient recruitment.

Press contact:

Sarah Hof

Marketing Associate, LINEA System

shof@lineasystem.com

LINEA System teams up with Trial By Fire in fully-integrated partnership

Posted on by Sarah Hof

 

PARSIPPANY, NJ and OAKLAND, CA - LINEA System, LLC and Trial By Fire Solutions, LLC have begun a partnership to offer their clinical trial solutions, AcceleTrial™ and SimpleTrials, respectively, as a fully integrated solution. This partnership will allow sponsors to take advantage of AcceleTrial™’s study start-up benefits to select and activate the right sites, and of SimpleTrial’s robust clinical trial management system (CTMS) capabilities.

LINEA System’s Study Start-Up System (SSUS) provides access to a built-in global database of over one hundred thousand objectively-ranked investigators and sites as well as an intuitive and automated workflow to ensure study start-up progresses efficiently. SimpleTrials provides end-to-end study management functionality, including eTMF, electronic visit reports, and site payments, fully validated and available as the industry’s first on-demand subscription based CTMS offering.

“Having LINEA System as a partner enables our clients to more effectively identify and qualify sites based on specific criteria” said Nancy Cecchettini, Co-founder and Chief Product Officer of Trial by Fire Solutions. “For more than a decade, we have provided comprehensive CTMS functionality to manage study start-up through closeout and this partnership will enable our clients to quickly move through the site selection and document completion aspects of their studies with one end-to-end service.”

The synthesis of LINEA Systems’ and SimpleTrials’ technologies will result in a more seamless execution of clinical trials from beginning to end. When a trial is optimized and proceeds efficiently, vital medicines reach patients who need them most.

“The current climate demands that clinical teams approach trials in an advanced way, considering all the hurdles to speed availability of critical treatments to patients” said Kathleen Colatrella, Founder and President of LINEA System. “I’m excited to begin the partnership with SimpleTrials and share the value of an SSMS with more clinical teams, and ultimately, make an impact on how trials are conducted.”

Colatrella and Cecchettini are excited to launch their partnership at such a time when efficiency and accuracy of clinical trials are more crucial than ever.

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About LINEA System, LLC

LINEA System is a leader in helping accelerate clinical trials by leveraging data and automated technology in a completely new way. The company specializes in clinical site and investigator identification, feasibility, and site activation. LINEA System’s cloud-based Study Start-Up System (SSUS), AcceleTrial™, enables sponsors to streamline and automate the study start-up process to drastically reduce the launch time of clinical trials and patient recruitment. For more information, visit http://www.lineasystem.com.

About Trial By Fire Solutions, LLC

Trial By Fire Solutions is a global leader in web-based clinical trial management solutions focused on innovative applications to improve planning, execution and tracking of clinical studies. With its SimpleTrials CTMS product, along with an experienced clinical technology team, Trial By Fire Solutions provides affordable eClinical solutions to teams of all sizes. For more information, visit http://www.simpletrials.com.

Press contact:

Sarah Hof
Marketing Associate, LINEA System
shof@lineasystem.com

Why is a Study Start-up Management System the vital tool sponsors need?

Posted on by Sarah Hof

By: Sarah Hof

 

Countless industries are shifting to virtual and remote operations, and the realm of clinical trials is no exception. In fact, COVID-19 has only accelerated our industry’s dependence on technology to efficiently and successfully run trials. This shift has prompted the field to accept virtual or decentralized clinical trials as a trusted means to conduct research of such vital importance.

As teams become empowered to work from anywhere in the world, it is necessary for all stakeholders in a trial to have readily-available access to information on the clinical trial in real-time. The proper tools and technology to navigate a decentralized clinical trial ensures a successful outcome for the sponsor, and more importantly, an accelerated timeline for patients to gain access to life-changing medicines.

What is a Study Start-up Management System?

A Study Start-up Management System (SSMS) is an essential tool to efficiently accelerate clinical trial start-up. Throughout all steps in the start-up process including targeting the right sites, assessing site interest, conducting feasibility, collecting essential regulatory documents, obtaining approvals and contracts, and finally, enrolling patients, an SSMS ensures that a trial launches on-time and with the optimal sites.

There are three hallmark features of an SSMS:

  1. A built-in database of investigators. To deliver the optimal sites, every SSMS includes a built-in investigator database.
  2. An automated workflow. By design, the system’s automated workflow enables a sponsor to quickly move from task to task and ensure that the start-up is progressing with no hold-ups.
  3. A cloud-based structure. The cloud-based nature of the system provides readily available access to data, metrics, and reporting anytime and anywhere.

Differing from other trial management software, an SSMS assists in the launch of a trial, while others such as a CTMS, manage separate aspects of a trial after it has been launched and patients are being enrolled.

How can an SSMS help sponsors?

It is well-known that the most common source of delays to a trial is patient recruitment. This stems back to sponsors selecting initial sites that either prove unreliable once patients have been enrolled, or fail to enroll patients all together. In fact, according to the Tufts Center for the Study of Drug Development, 37 percent of sites selected under-enroll, and 11 percent fail to enroll a single patient. These routinely poor start-up metrics can lead to delayed trial timelines, and a 20 percent or higher increase in the originally projected trial budget.

When a sponsor selects the optimal sites first, patient recruitment is realized, the trial can proceed on-time, and the sponsor gains approval of vital medicines sooner. This efficient sequence of the events is possible using a Study Start-up Management System, with the built-in database of ranked investigators and an automated workflow to effectively launch the trial.

How does AcceleTrial™ drive clinical trials forward?

AcceleTrial™ was created with the founding principle that nearly all clinical trials can avoid delays by selecting the right sites initially. Not only does AcceleTrial™ have a database of over 100,000 global expert investigators, those investigators are all ranked objectively. Its proprietary algorithm pulls hundreds of data points from multiple sources based on clinical expertise, access to patients, and former clinical trial experience, among other metrics. This powerful ranking system ensures that ultimately, the most effective and optimal investigators and sites are selected for the trial, thereby mitigating the chance of delay.

The “push and pull” workflow ensures a steady momentum, tracking each step and keeping the process seamless. To add transparency, both the sponsor and the investigators are able to access the platform and complete their respective tasks while monitoring the full scope of the process. AcceleTrial™ is designed to be intuitive and make a significant and immediate impact on a trial’s launch time and operational costs.

When a trial progresses smoothly, the greatest value is the potential to make available life-changing medicines for patients who need them most.

Learn more about AcceleTrial™ here. 

 

LINEA System: Advanced Technology for Accelerating Clinical Trial Launch

Posted on by Sarah Hof

 

LINEA System is proud to have been recognized by MD Tech Review as a Top eClinical Trial Management Solution Provider for our work to accelerate clinical trials! To read the full story and see the spread, please visit their website, or click the PDF below.

 “AcceleTrial™ identifies sites based on objective data validating therapeutic expertise, clinical trial experience, and access to patients that provides transparency for sponsors in choosing the right site. This model takes the guesswork out of clinical trial site identification and combined with an automated workflow, accelerates clinical trial start-up.”

-Kathleen Colatrella, Founder and President