Strategically Designed Concept to Clinic Support & Research Management
CLINICAL RESEARCH PROJECT DEVELOPMENT AND MANAGEMENT
About Us
Why ETSLLC
Experience the Difference
How We Help
Harnessing extensive research management experience to develop strategic approaches for your clinical research helps reduce unnecessary regulatory obligations, excessive operational costs, and extended timelines, which takes your concepts to clinic subjects with maximum efficiency.
How We Help
Experience the Difference
How We Help
We maximize our knowledge of national and regional regulatory requirements with the experience of validated medical research and developmental approaches to efficiently and expeditiously navigate your research projects through all appropriate channels, allowing your research to meet all oversight and stakeholder obligations without excessive processes.
Experience the Difference
Experience the Difference
Experience the Difference
ETSLLC's clinical trial management goal is to ensure your projects meet regulatory standards, research benchmarks, and financial milestones without extending timelines, because your goal is a successful research outcome.
Our Services
Protocol Development
ETSLLC has helped investigators write over 150 research projects from non-invasive data collections and observational trials to Phase II-III multi-institutional clinical trials.
We will take your clinical and scientific concepts and help you design the most strategic approaches to regulatory approval without compromising safety, efficacy, or efficiency.
Regulatory Approvals
Whether you have a novel clinical concept or a protocol in hand, ETSLLC will provide the most efficient way to navigate your project through all necessary regulatory approvals. We have worked with academic, industry, and federal regulatory agencies to build an extensive understanding of reviewing agencies' requirements to limit costs and timelines related to reviews and approvals.
Research Partnering
ETSLLC has helped investigators develop multi-institutional research consortiums in data collection, imaging acquisition, and clinical interventions. Leveraging a network of leading institutions and researchers will help you find the right partners for your research projects.
Associated Services
Budgeting, vendor sourcing, and contracting are all part of research projects, and can be critical to timely and successful outcomes. We have over 10 years of experience with philanthropic, industry, and government resource management allowing us to maximize the benefit of your essential resources without compromising your research goals.
One Stop Shop
ETSLLC is a personalized approach to your research planning. Guided by regulations, experiences, and desired outcomes we will help you take your concept to your clinic without the excessive hurdles applied to general and uninformed approaches.
Personalizing Clinical Research Applications
Research Experience
Registered Clinical Trials (NIH Criteria)
Current:
Prostate Assessment With Restriction Spectrum Imaging (RSI) MRI
https://beta.clinicaltrials.gov/study/NCT04992728
Biomarker Monitoring of Prostate Cancer Patients With RSI MRI (ProsRSI)
https://beta.clinicaltrials.gov/study/NCT04349501
Phase II Randomized Trial of Radiotherapy With Concurrent and Adjuvant Pembrolizumab (Keytruda®) Versus Concurrent Chemotherapy in Patients With Advanced/Intermediate-Risk p16+ Head and Neck Squamous Cell Carcinoma (KEYCHAIN)
https://beta.clinicaltrials.gov/study/NCT03383094
Quantifying Radiation Induced Vaginal Stenosis (QRIVS)
https://beta.clinicaltrials.gov/study/NCT05002751
QUantitative Assessment of Swallowing After Radiation (QUASAR)
https://beta.clinicaltrials.gov/study/NCT04359199
Previous:
An Open-label, Non-randomized, Multi-arm, Phase II Trial to Evaluate the Efficacy of Pembrolizumab Combined With Cetuximab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
https://beta.clinicaltrials.gov/study/NCT03082534
An Open-label, Single-arm, Multi-institutional Phase II Trial of Avelumab for Recurrent, Metastatic Nasopharyngeal Carcinoma
https://beta.clinicaltrials.gov/study/NCT02875613
An Open-Label, Phase 2 Efficacy Study With Window of Opportunity Immune Assessment of Pembrolizumab in Relapsed, Locally Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
https://beta.clinicaltrials.gov/study/NCT02769520
A Phase 1b Safety and Feasibility Study of Personalized Immunotherapy in Adults With Advanced Cancers
https://beta.clinicaltrials.gov/study/NCT03568058
Some of our partnering project publications include the following:
Effectiveness of Cisplatin in P16+ OPSCC Patients According to Relative Risk for Cancer Events: Ancillary Analysis of RTOG 1016Effectiveness of Cisplatin in P16+ OPSCC Patients According to Relative Risk for Cancer Events: Ancillary Analysis of RTOG 1016
2023 American Society for Radiation Oncology (ASTRO 2023)
- ASTRO 2023 Oral Presentation Authors: Hannah C. Liu, Ryan T. Morse, Tyler J. Nelson, Casey W. Williamson, Lucas K. Vitzthum, Kaveh Zakeri, Gerald Henderson, Caroline A. Thompson, Jingjing Zou, Maura L. Gillison, Loren K. Mell Purpose: To test the hypothesis that the effectiveness of cisplatin in p16+ OPSCC increases with patients’ relative risk for cancer events.
Quantitative Prediction of Aspiration Risk in Head and Neck Cancer Patients Treated with Radiation Therapy
https://www.sciencedirect.com/science/article/pii/S1368837522005371?via%3Dihub
Advanced quantitative diffusion MRI as a biomarker of treatment response in patients with localized prostate cancer undergoing radiotherapy (RT) and androgen deprivation therapy (ADT) Prostate Cancer Foundation Scientific Retreat Oct 1, 2022
- Accepted abstract at Prostate Cancer Foundation Retreat 2022. Authors: Tyler M. Seibert, Roshan Karunamuni, Christopher C. Conlin, Troy Hussain, Joshua Kuperman, Gerald Henderson, Karoline Kallis, Allison Zhong, Leonardino A. Digma, Ian T. Mathews, Nikki Phan, Deondre Do, Asona J. Lui, Ahmed Shabaik, Brent S. Rose, John P. Einck, Tyler F. Stewart, Ajay Sandhu, Arno J. Mundt, James Urbanic, Aditya Bagrodia, Christopher J. Kane, Jingjing Zou, Sophia Kamran, Mukesh Harisinghani, Rebecca Rakow-Penner, Michael E. Hahn, Anders M. Dale RT is integral to curative treatment of the most aggressive csPCa. Many patients also require systemic therapies—with accompanying serious side effects—but we do not precisely know how to determine duration or type of therapy for a given patient after radiotherapy. Currently, we try to predict efficacy for each patient based on csPCa grade/stage at diagnosis. A strategy used in other cancers is to measure the actual tumor response and then base decisions on whether the treatment is working. Early response assessment could allow personalized duration (which can vary by years) and intensity of treatment to maximize possibility of cure while preserving quality of life. Apparent diffusion coefficient (ADC) has proven unreliable for this purpose, likely because its simplistic model cannot distinguish treatment effects on extracellular tissues from decreases in tumor cellularity. Restriction Spectrum Imaging restriction score (RSIrs) is based on a more sophisticated model and yields a quantitative imaging biomarker of cancer.
Services
The clinical research process can be very complex, but the core requirements are standardized. ETSLLC has the experience and templates to perform the following:
- Protocol Writing (as needed, informed consent documents, HIPAA consents, case report forms, subject questionnaires/QoLs)
- Institutional Review Board Submissions (Institutional, central, eBRAP)
- FDA IND/IDE submissions
- clinicaltrials.gov postings
- Grant Preparation (NIH, DoD, Local Intramurals)
- Vendor Sourcing (lab supplies, testing, advisory)
- Budgeting
- Contracting (confidentiality disclosure agreements, sub-site agreements, data use and sharing agreements, material transfer agreements)
- Clinical Site evaluations and management
- Trial Master File Management
- Data collection and database management
If you have questions about a particular service for your research application, please contact me and I will help plan accordingly.
Patient-Focused Research
Some time in the course of life we're all patients and at Expedient Trial Solutions LLC, we're committed to putting patients first. Our strategic planning process is designed to limit extraneous add-ons in order to deliver your research goals and improve patient outcomes.
Collaborative Partnerships
Rarely have results been produced in a silo. ETSLLC has been built on collaboration and that has helped investigators find the partners needed to gather subjects, data, and publications. Leveraging these collaborations will help ETSLLC provide you with the partners necessary to complete your research projects in the quickest timeframes possible.
ETSLLC is proud to showcase current collaborations:
Dr. Loren Mell's Lab: https://medschool.ucsd.edu/som/radiation-medicine/research/labs/mell-lab/Pages/People.aspx
Dr. Tyler Seibert's Lab: https://www.seibertlab.com/team-1
SOTERIA Precision Medicine: https://www.soteriaprecisionmedicine.org/soteria-team
Innovative Solutions
We're always looking for new and innovative ways to approach medical research. Not only is our team constantly exploring new technologies, techniques, and approaches to achieve our goals, but we exercise knowledge of current paradigms and regulations, as well as previous successful approaches to critically apply personalized strategies for every project.
Industry Recognition
Our groundbreaking research has earned us recognition as leaders in the medical research and development industry. Our partners are all industry leaders with innumerable projects and publications to their credit.