Validcare’s approach is tailored to meet the regulatory and budgetary needs of small biotech.
CASTLE PINES, CO — TECLens, LLC has chosen Validcare to provide protocol development, e-source data collection, data management and statistical analysis services for its upcoming ophthalmic study. The use of TECLens proprietary quantitative corneal cross-linking (qCXL™) technology could improve reading vision in patients with presbyopia.
This proof-of-concept study will lay the groundwork for the full clinical development of the TECLens refractive cross-linking product for presbyopia patients (patients over 40 years old with a natural crystalline lens who struggle with reading distance vision).
“Optimizing the capture of clinical data will allow us to quickly and efficiently fine tune our clinical program” said Patrick Lopath, COO of TECLens. “Validcare’s approach to data collection and data management provides us the flexibility that is critical to us in this early stage of development, allowing us to be fast and agile as we design the larger-scale studies. Validcare’s services are seamlessly scalable, ready to grow with us as our clinical programs expand in scope.”
Validcare’s cloud-based 21 CFR Part 11 compliant clinical trial data platform will be configured to collect clinical and technical data from the investigators, patient feedback and ocular imaging equipment in a unified database. This approach reduces data management by an estimated seventy percent (70%) vs. traditional methods and allows direct analytical and statistical analysis.
“We understand time and budget are significant constraints for the development of new medical innovations. We take great pride in helping optimize TECLens’ limited resources to reach the goal of bringing its vision-changing therapies to market in a rapid, safe, and compliant manner” said Rod Nuss, COO Validcare.
Validcare is a high-performance Contract Research Organization (CRO) uniquely skilled at de-risking the execution of clinical studies for pharma, biotech and medical device companies, spanning all therapeutic areas. Its revolutionary approaches give sponsors unmatched visibility and control to complete studies on time, on budget, and with high data integrity. Founded by experts with more than 30 years of executive-level industry experience, Validcare is a trusted advisor and strategic business counsel to its sponsor clients, helping to bring life-changing products to market.
For more information, visit validcare.com or call 844-825-4322.
TECLens is leading the transformation of refractive vision care. The company has developed a novel, incisionless technology called quantitative corneal cross-linking or qCXL™ that can reshape the cornea without laser-ablation or invasive surgery. qCXL™ may be used to free presbyopic patients from the need for reading glasses, to prevent children from developing high myopia and to treat keratoconus. TECLens believes its platform technology will revolutionize the existing standard of care for these and other eye conditions. TECLens’ goal is to make its simple, cost-effective qCXL™ procedure the primary choice for patients seeking refractive correction, improving vision for millions of patients around the world.
For more information, visit teclens.com.