Primary Endpoint Solutions
Primary Endpoint Solutions (PES) specializes in optimizing clinical trial data quality, particularly focusing on endpoint data accuracy, training, review, and centralized scoring. Their mission is to support clinical trials by ensuring high-quality, consistent, and reliable endpoint data, thereby increasing the chances of trial success, reducing costs, and accelerating timelines. PES offers a range of services including trial preparation, clinical rater training, expert data review, ancillary clinical supplies, radiation therapy quality assurance, and genomics & biomarkers support. Their vision is to mitigate trial risks and improve the integrity of clinical trial data through innovative, expert-driven solutions.
Industries
Nr. of Employees
small (1-50)
Primary Endpoint Solutions
Watertown, Massachusetts, United States, North America
Products
Radiation Therapy Quality Assurance
Expert review of radiation therapy treatment plans for oncology-related clinical trials to confirm uniformity of treatment and mitigate variability.
Radiation Therapy Quality Assurance (RTQA) Services
Expert review of radiation therapy treatment plans to confirm uniformity of treatment in clinical trials.
Ancillary Clinical Supplies
Design, supply, and tracking of ancillary clinical supply kits to support the successful execution of clinical trial protocols.
Clinical Rater Training Services
Web-based training and curriculum design services that turn site-based clinicians into effective clinical raters and assessors for clinical trials.
Centralized Scoring
Centralized scoring of observed symptoms by on-team indication-expert reviewers to reduce variability introduced by site-based clinical raters.
Real-time Expert Data Review
Proprietary methods including real-time endpoint data quality review (EdQ) designed to minimize risk and augment accrual, compliance, and retention in clinical trials.
Radiation Therapy Quality Assurance
Expert review of radiation therapy treatment plans for oncology-related clinical trials to confirm uniformity of treatment and mitigate variability.
Radiation Therapy Quality Assurance (RTQA) Services
Expert review of radiation therapy treatment plans to confirm uniformity of treatment in clinical trials.
Ancillary Clinical Supplies
Design, supply, and tracking of ancillary clinical supply kits to support the successful execution of clinical trial protocols.
Clinical Rater Training Services
Web-based training and curriculum design services that turn site-based clinicians into effective clinical raters and assessors for clinical trials.
Centralized Scoring
Centralized scoring of observed symptoms by on-team indication-expert reviewers to reduce variability introduced by site-based clinical raters.
Real-time Expert Data Review
Proprietary methods including real-time endpoint data quality review (EdQ) designed to minimize risk and augment accrual, compliance, and retention in clinical trials.
Services
Advisory engagement to evaluate and select study endpoints, draft protocol elements, design data capture strategies, assist CRO selection, and advise on initial regulatory interactions.
Design, localization, administration, and tracking of custom online training modules and assessments for site investigators and raters; provides auditable completion records.
Real-time review of all reported subject assessments, protocol-specific worksheet design, immediate feedback to sites, centralized scoring by indication experts, and submission-ready validated scores.
Design, procurement, in-house packaging/labeling, warehousing, temperature-controlled and routine shipping of ancillary clinical supply kits, with inventory tracking and real-time resupply.
Clinical review and management of radiation treatment plans and RTQA documentation to ensure conformity with protocol prescriptions and dose parameters.
Support for biomarker identification and application, sample collection training, biobanking, assay performance oversight, and analytic applications for genomic/epigenomic/demographic data to inform mechanism and responder populations.
Advisory engagement to evaluate and select study endpoints, draft protocol elements, design data capture strategies, assist CRO selection, and advise on initial regulatory interactions.
Design, localization, administration, and tracking of custom online training modules and assessments for site investigators and raters; provides auditable completion records.
Real-time review of all reported subject assessments, protocol-specific worksheet design, immediate feedback to sites, centralized scoring by indication experts, and submission-ready validated scores.
Design, procurement, in-house packaging/labeling, warehousing, temperature-controlled and routine shipping of ancillary clinical supply kits, with inventory tracking and real-time resupply.
Clinical review and management of radiation treatment plans and RTQA documentation to ensure conformity with protocol prescriptions and dose parameters.
Support for biomarker identification and application, sample collection training, biobanking, assay performance oversight, and analytic applications for genomic/epigenomic/demographic data to inform mechanism and responder populations.
Expertise Areas
- Endpoint optimization and data quality assurance
- Clinical rater training and certification
- Clinical trial design and protocol development
- Centralized scoring and adjudication
Key Technologies
- Web-based training platforms (LMS)
- Biobanking infrastructure
- Genomic and epigenomic analytics
- Machine learning for genomic feature selection
News & Updates
PES leverages Adobe’s Captivate Prime LMS to improve endpoint accuracy, increase trial success chances, decrease drug development costs, and accelerate timelines.
A review focusing on small molecules and biologicals for preventing or treating oral mucositis caused by cancer treatments.
A comprehensive literature review on the effectiveness and biological pathways of low-level laser therapy in mitigating oral mucositis.
An article discussing how cytokine-induced blood-brain barrier disruption may contribute to neurotoxicity and cognitive issues in cancer patients.
A study on gene dysregulation predicting fatigue in prostate cancer patients undergoing radiotherapy.
Research on the activation of the PI3k/Akt/mTOR pathway in oral diseases and its potential link to oral cancer.
PES leverages Adobe’s Captivate Prime LMS to improve endpoint accuracy, increase trial success chances, decrease drug development costs, and accelerate timelines.
A review focusing on small molecules and biologicals for preventing or treating oral mucositis caused by cancer treatments.
A comprehensive literature review on the effectiveness and biological pathways of low-level laser therapy in mitigating oral mucositis.
An article discussing how cytokine-induced blood-brain barrier disruption may contribute to neurotoxicity and cognitive issues in cancer patients.
A study on gene dysregulation predicting fatigue in prostate cancer patients undergoing radiotherapy.
Research on the activation of the PI3k/Akt/mTOR pathway in oral diseases and its potential link to oral cancer.