Symbio

Complex Dermatology Clinical Trial Nuances Simplified: Rely On Experience

As the top global niche cro Specializing in dermatology, Symbio has simplified the Journey of successful Dermatology products from Formulation through final Approval.Skin. Everyone has it. Dermatology clinical
Trials are different and success in dermatology requires decades of experience. How are they different? Dermatology clinical trials on average run must faster than industry. Some published averages of phase 3 trials have a duration Of 1000 days, whereas the average symbio dermatology phase 3 trials duration is 580 days. Symbio leverages experience in dermatology and utilizes efficiencies and staff accustomed to the pace to streamline the process.

Fail to plan, plan to fail. A common perception is that CROs under budget to secure a study. Some investigation into this has suggested that CRO revenue is 70% contracted costs + 30% scope changes. This could be either intentional or because the CRO does not fully understand what is required. With the benefit of experience, Symbio is able to generate a superior plan for Dermatology clinical trialsand on average Symbio invoices 96% of the contracted budget and does not rely on scope changes. This means the initial plan is accurate based on experience.

Dermatology assessments are easy. Sure, maybe Dermatology assessments seem easy to someone who is not an expert in Dermatology, but it is this thinking that, unfortunately for too many Sponsors recently who have invested heavily in Phase 3 Dermatology trials, and for the potential patients who would have benefited from that approved drug, has resulted in recent failed Phase 3 Dermatology trials. Investigator selection and training are key, particularly where subjective assessments are primary endpoints.

Symbio has decades of metrics on Investigators who not only enroll well for fast paced Dermatology clinical trials, but as paramount, Symbio maintains metrics on Data Quality to equip Sponsors with knowledge for proper site selection. Symbio also has proven methods to train Investigators on proper assessments to maximize the potential of a successful trial.

Dermatology clinical trials require indication expertise to be successful. The ultimate goal is a fast, masterfully managed clinical trial in an effort to provide approved products based on top quality data for patients suffering so many Dermatology indications around the world.

Many Sponsors have selected Symbio as their preferred CRO and also awarded Women’s Health and Ophthalmology trials which have led to successful products approved by FDA that are currently marketed.

Symbio is a niche CRO specializing in Dermatology with offices in the US and Europe. Since 2002, Symbio has conducted over 140 clinical Phase 1-4, POC, and Device trials in Dermatology and has been part of 50 FDA approvals with many more pending. Applying trial management expertise, Symbio has also enjoyed much success in Women’s Health and Ophthalmology.

With core CRO services in house including Project Management, Medical Monitoring, Site Monitoring, Data Management, Statistics and Medical Writing, and the Formulation and Manufacturing talents at Symbio’s wholly owned subsidiary, Dow Development Laboratories, Symbio is the only global CRO specializing in Dermatology from Formulation through clinical trials, through final approval.

symbioresearch.com

Symbio,LLC


+1-631-403-5123
21 Perry Street Port Jefferson
New York 11777 United States
ctroller@symbioresearch.com

Submit your Innovation Story

Join and network with a global community of innovators  by sharing your success story with the world.