HOW WE WORK

Clinical trials are extremely expensive, yet many rely on clinician-based assessments that are broadly inconsistent.​

Our primary objective is to help you mitigate trial risk by providing you with pristine data across sites and assessors. PES supports several key domains within trials, including endpoint selection, customized web-based training for all site assessors, real-time data quality review, and centralized scoring and grading of patient assessments.​

Through our integrated set of services, we guarantee the highest quality endpoint data for our clients.

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Laying the Foundation for a Successful Trial

Well-run trials begin with a good team, the right endpoints, and confident first steps. We can help.​ PES will often be engaged before a CRO is selected, collaborating with the sponsor’s clinical team to:

  • Assist in the selection of the study endpoints as part of the protocol development, with careful consideration of clinical, regulatory, and commercial meaningfulness

  • Engage experienced indication-specific clinical thought leaders as team members

  • Establish collaborative relationships with sponsor, CRO, and sites to facilitate all aspects of endpoint selection and data collection, analysis, and interpretation

  • When needed, assist in the identification and development of surrogate biological endpoints and relevance to clinical endpoints
     

Tools and Training

Recognizing that endpoint data quality is foundational to your success, we customize tools and web-based training to meet specific protocol endpoints. To optimize the accuracy and consistency of data that is submitted from trial sites, PES will: 

 

  • Design tools that enable uniform, disciplined, and complete data collection for the trial’s specific clinical endpoints

  • Train investigators, CRO personnel, and other study personnel on the indication, administration of the data collection tools, and data capture; validate competencies

  • Provide all study personnel with custom web-based training modules designed to optimize data collection accuracy

  • Administer the web-based training in the local native language when needed

  • Train on sample collection when surrogate biological endpoints are needed

  • Establish a database for real-time endpoint data entry

 

Real-Time EdQ™

PES’s proprietary methods minimize risk and augment accrual, compliance, and retention.  Central to these methods is the real-time endpoint data quality (EdQ™) that PES provides. To ensure that your study yields a consistent and complete dataset, PES will:

 

  • Perform real-time review of all patient subject assessments, validating completeness and consistency

  • Provide immediate feedback to investigators and sites; flag gaps in accuracy, compliance, and any unexplained anomalies; provide feedback to sponsor and CRO for correction

  • Model endpoint data to assess potential efficacy signal(s)

  • Provide CRO with metrics to optimize study subject retention; dropout monitoring and analysis

  • Provide analysis, interpretation, and endpoint consultation throughout trial 

 

Centralized Scoring

When protocols require that severity scores be provided (based on patient subject symptoms or observations), site assessors can introduce an enormous amount of variability into a trial’s dataset.  Site assessors frequently have different interpretations of how to map the severity of symptoms to a scoring scale. As part of PES’s integrated services, we centralize this scoring and take the scoring responsibility out of the hands of the sites.

Within a regimented process, PES will:

 

  • Provide site assessors with a customized protocol-specific worksheet for gathering patient and symptom observation

  • Review all submitted assessments for completeness and consistency

  • Have an on-team indication expert review the submitted data and provide a score or grade

  • Perform a final validation of the patient assessment / score, and submit the data to the CRO for recording

 

Genomics & Biomarkers

PES is frequently engaged to provide support for biomarker identification and genomics for clinical trials. We have a team ready to:

  • Assist in the application of surrogate biological endpoints (i.e. biomarkers) to validate an agent’s mechanism of action (MOA) and relevance to clinical endpoints; sample collection training, biobanking, and assay performance

  • Provide proprietary analytic applications for genomic, epigenomic and demographic inputs to establish and/or expand MOA claims (all new IP discovered belongs to client) and differentiate responder/non-responder populations
     

 
Contact us today to reduce risk and improve your results.
About Primary Endpoint Solutions​

PES’s integrated services eliminate inconsistent and incomplete trial data, ensuring that the selection, capture, accuracy, and analysis of endpoints is optimized.

© Copyright Primary Endpoint Solutions 2019

Contact​

313 Pleasant Street

Watertown, MA 02472

info@pesclinical.com