The Prosoft Electronic Data Capture (EDC) system worked really well in our multi-year clinical program leading to our Total Posterior Spine (TOPS) facet joint replacement system PMA approval. Prosoft Data Management and their support team worked closely with us, and we are grateful for the consistent professionalism demonstrated for the duration of this extended program. Thank you Prosoft!

~ Jeff Withrow, VP Clinical Affairs, Premia Spine Ltd.
I enjoy working for a small, virtual pharma company. But sometimes things get a bit hectic and we need a more help – it could be in Regulatory, or CMC or Clinical. It could be an extended project or just a few hours here and there. Finding the right resource than can provide consistent quality work and performance for a variety of therapeutic areas, and be flexible with our crazy timelines was, of course, difficult. Until will found Prosoft Clinical about four years ago. Prosoft has experienced, professional and very friendly staff that can handle anything: from Project Management for FDA meetings, ANDA/NDA annual report submissions, product development strategies, Labeling review, to literature searches. One of the best decisions I have made.

~ From DH, a sponsor company….
Prosoft Clinical has provided exceptional clinical, data management, CMC, and statistical consulting services on a number of development projects. Their experience and diligence to getting the job right is what distinguishes them from other CROs. I recommend them without hesitation

~ James H Lee MD PhD Group Vice President, Head Inflammation and AutoImmunity Incyte Corporation
I have worked with Prosoft Clinical on multiple projects from Phase 1 through Phase 3 over the past several years and have used partial service to full service depending on the project. Prosoft Clinical’s team performs as if they were part of your own organization which I think sets them apart from other CROs. They are easy to work with no matter the scope of their services. We have had to have them rescue projects awarded other organizations in order to get the job done and meet timelines. Unlike some of the other CROs you aren’t nickled and dimed with change orders. Prosoft Clinical’s edc system is easy to use for both the sponsor and site personnel. Prosoft Clinical’s team has many years of experience working on the Sponsor side of the business so they understand their customers.

~ Sr. Director Clinical Operations
In my dealings with Prosoft Clinical as CEO of Encore and other organizations over the last 10 years, Prosoft Clinical have always been thorough, insightful, and timely. They are a professional group of individuals that understand not only the development process, but how to connect those activities with an eventual commercial outcome. We have relied on their expertise and customer oriented service to help us move various projects forward and have never been disappointed.

Prosoft Clinical gave me a price for Data Management and stuck to it. We had several small tweaks to the eCRF throughout the study which Prosoft managed within 48 hours and without a change order. No other CRO can match that for customer service!

~ Barbara Powers, MSN, Ph.D. President, Expedite Research, LLC.