Rationalizing Study Startup Budgeting and Contracting with RTP-based Clinistart

Rationalizing Study Startup Budgeting and Contracting with RTP-based Clinistart TrialsiteN

Research Triangle-based Clinistart represents the next wave of innovative cloud-based service providers to accelerate clinical trial site activation and study start up, contributing to what hopefully are more efficient and cost effective studies. The goal: accelerate each step of the clinical trials process to accelerate the availability of medicines sooner for patients. Based in Raleigh, North Carolina, this startup—just launched in 2020—already counts 11 clients and growing revenue. TrialSite’s founder Daniel O’Connor recently spoke with Clinistart founder Sam Searcy to learn more about this interesting venture.

Clinistart’s successful first year isn’t by accident as founder and CEO Sam Searcy shared with O’Connor that the venture’s board includes a well-respected James Erlinger, executive vice president and general counsel of Veracyte, Brad Wilson, CEO Emeritus of Blue Cross NC and Louise Winstantly with University of North Carolina at Chapel Hill.  As it turns out Mr. Erlinger served IQVIA (Quintiles) for several years as general counsel  and Searcy himself, a JD, spent several years at a couple prominent contract research organizations (CRO) including IQVIA and PRA Health Sciences.  Complementing Searcy is the company’s COO Tamara Oh. Upon earning her JD from University of North Carolina in 2019 she spent the last decade working on clinical trials contracts for major CROs.

The company specializes in delivering innovative solutions for sponsors and CROs focused exclusively on clinical trial contracting and grants management. The venture offers two solutions, including 1) a compelling service for the biotech and CROs that seeks to outsource their contracts and budgeting operation, and 2) software-as-a-service configured for contracts and budgeting. The latter offering is built on the Salesforce platform which has been widely adopted in the life sciences sector.

The company represents the next wave of best-of-breed, digital services targeting various activities and segments in the clinical trials value chain. The goal: drive out inefficiencies while bolstering productivity and quality. A combination of technology, domain expertise and ubiquitous cloud computing lead to relentless innovation in the clinical trials sector.

What is the value proposition?

Drug developers and CROs have many priorities involving the clinical trials startup and management process. For those firms that seek to embrace efficiency which can lead to not only lower costs but also quality output they consider outsourcing this emerging service and product.

A fundamental objective includes the reduction of administrative burden while eliminating frequent administrative bottlenecks involved with the contracting and budgeting process.

As it turns out a large number of new NDAs are filed not by big pharma but rather by new biotech—this must favor your business model?


Isn’t this kind of function just controlled by CROs or a CTMS product?

Not really, reports Searcy. The CTMS (clinical trial management system) is cumbersome, heavy and not designed for agile contracting and budgeting processes. Moreover, many new biotech’s want to focus on the business of science leaving the nuts and bolts of contracting and budgeting to seasoned, competitive groups with deep expertise and commitment via service level agreements.

How much money have you raised?

We closed a Series A for about $ 1 million

How many clients do you have and are you profitable?

We have 11 clients and growing—and yes we are profitable.

How many employees do you have?

Currently, 10 plus a network of contractors to help us scale for clients

Where is the product headed?

Well, we are building out ever more rich functionality, integrating seamlessly with Office 365 and will look to natural organic expansion to add ever more value to our clients.

Call to Action: Private equity investors should keep an eye on this venture. Research centers, biotech and CROs interested in outsourcing their contacts and budgeting should consider Clinistart. TrialSite invited Clinistart to present on the TrialSite Podcast show.