Optimizing Study Start-up Through People and Technology

Since 2008, LINEA System has been helping to eliminate the many challenges that exist with the typical study start-up model. In fact, LINEA was founded to improve the entire process for Sponsors and CROs, who had previously been forced to deal with delays and frustrations. We exist to eliminate those delays and frustrations and to identify, qualify and initiate the “right” sites in less time, and with greater value, than ever before.

Our people, coupled with our technology – AcceleTrial®, utilize objective and subjective data, along with our proprietary algorithms, to access, extract, normalize, index, and integrate the information that you need. Our vast network of 300,000+ global investigators and clinical research sites uniquely empowers us to create a customizable site identification plan for your unique protocol and program. The result – the identification and access to the qualified sites, and best sites for your study, while realizing optimal sponsor and site satisfaction, due to the highly efficient and effective processes that we utilize.

LINEA System – helping you to achieve world-class study start-up results while saving time and money

Study Start-up Facts

Study start-up represents the “first impression” for any new clinical trial and the respective participating clinical trial sites. And, as the old saying goes, you don’t get a second chance to make a good first impression. Effective, efficient, objective, evidence-based study start-up sets the tone for both sponsors and sites for that study. LINEA System can make that first impression a great one.

End-to-End Process for Sponsors, Simplified

1

Identification

Use evidence-based data to target sites with the right patients for your trial

2

Feasibility Questionnaire

Access responses in real-time for quick insight on your site’s capability to conduct the trial

3

Site Visit

Schedule dates for Pre-Study Site Visit and Site Initiation Visit to qualify sites, and provide training

4

Clinical Trial Agreement

Expedite contracts and initiate sites to accelerate patient enrollment

5

Regulatory / IRB

View regulatory essential documents and manage IRB/Ethics approvals

6

Drug Shipment

Monitor drug request and shipment

7

Enrollment

Track screening and enrollment to confirm activation

How We Help Sites

End-to-End Process for Sites, Simplified

1

CDA

Expedite the Confidential Disclosure Agreement with auto-fills and digital signature

2

Feasibility Questionnaire

Immediate access to questionnaires to provide insights on site capability

3

Qualification

Provide required documents and coordinate sponsor visits

4

Clinical Trial Agreement

Facilitate negotiations on contracts with accuracy and clear communication

5

Regulatory / IRB

Upload essential regulatory documents and track IRB/Ethics submission and approvals

6

Enrollment

Report and track screening and enrollment to confirm activation

What Do Customers Think…

Clients

Accelerate clinical trails

We are proud to be recognized by MD Tech Review for our advancements in the clinical space!

To learn more about our first-of-its-kind Study Start-Up System (SSUS) and read the Q&A with our Founder and President, please click here.