OneSource Regulatory
Achieving Optimal Regulatory Outcomes with Expertise and Technology

With the prevailing data deluge in most enterprises, the ability to unlock, search, mine, extract, and build insights from data-sets can go a long way in accelerating product development. Despite the increase in digitized data, only large organizations see the benefit for the most part, and smaller companies get sidelined because they don’t have funds or resources to leverage the tools or expertise needed to gain insights from their data. When Robert Merrill and Tracy Rockney looked at this huge void in the services and technology sector in the pharmaceutical and biotechnology regulatory space, they decided to invest their expertise and their shared passion for helping improve the regulatory and compliance schema into laying the cornerstones for OneSource Regulatory, founded in 2015. Merrill believes that OneSource Regulatory is uniquely situated to deliver simple and focused technology-enabled solutions and services to impact regulatory and compliance outcomes. “Seeing these challenges firsthand, we set out to assist our clients in implementing technology solutions and expertise to help them accelerate drug development and improve communications and marketing messages for their pharmaceutical and biotechnology products.”

The first aspect OSR focused on was its own workforce. Rockney emphasizes that OSR recruits highly experienced and technology savvy team members that can bridge the gap between the regulatory environment and achieving the objectives of their clients. Their employees understand the questions to ask and can help companies with the right information to guide them. And OSR staff are all remote workers. “If we were going to tackle large data issues, we first wanted to demonstrate our ability to tackle another pressing issue—hiring qualified staff no matter where they lived. If we could hire the best minds and have them surpass expectations regarding work quality and productivity, we knew we could take on the next big problem—data.”

With the overflow of information, finding the right data to answer important questions that are consistently asked by regulators is key for large enterprises as well as smaller companies. Creating timely solutions that can democratize the data and information for all companies will not only improve regulatory compliance, but will also help companies develop stronger regulatory strategies, leading to more approvals of products that are needed by patients.

An essential factor that OneSource Regulatory focuses on is to make data “searchable.” Most of the information in the regulatory space is not easily accessible, hindering data mining efforts. Finding the right guidance or answers is almost impossible without spending hundreds to thousands of staff hours reading through countless documents.

OneSource Regulatory launched MyIndago in October 2017, which allows regulatory and compliance professionals to search and understand FDA enforcement actions to avoid problems within their own organizations. The goal of the solution is to help guide better marketing decisions. The follow-on solutions OSR plans to introduce will continue to help companies understand additional regulatory information and answer questions they have around drug development and marketing. Quarrius by OSR is a proprietary tool that OSR will introduce in early 2019 to help companies find the answers to expertly navigate the onerous regulatory environment.

We focus on one solution at a time to make sure organizations of all sizes have tools that maintain compliance and regulation in the biotechnology and pharmaceutical space

Before developing and offering a solution, OSR ensures they understand client company objectives while using OSR staff expertise to solve the pressing challenges they face. In order to accomplish their future goals, OSR has developed an extensive roadmap of expert services and technology solutions to help companies improve their strategies and grow.

Over the past 3.5 years, OSR has successfully supported the launch of 20 drug/biologic products using their review expertise and technology solutions. OSR is working to not only help companies launch their products with the best information and strategy that is available, with 10 other products in their development roadmap, the company is keen on using technologies such as machine learning and AI to facilitate a more efficient working environment.

OneSource Regulatory believes that CIOs and data stewards within organizations are the critical links to help companies understand how to get access to the data that can help with the development and regulatory aspects of drug development. Companies who want to seek insights and learn from the data can partner with OSR to achieve better regulatory outcomes.