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Lineberry Research Associates (LRA) is a pharmaceutical Contract Research Organization (CRO) and strategic consulting firm located in Research Triangle Park, NC. LRA's client roster includes more than 70 major and emerging pharmaceutical companies, biotechnology organizations, and other pharmaceutical consulting firms. Since its inception in 1995, the company has consistently been recognized as one of the top 50 fastest-growing technology companies in North Carolina.

LRA offers a range of services that includes consulting on all aspects of drug development, clinical trial design and management, and a variety of scientific and regulatory writing capabilities. The company has prepared numerous Investigational New Drug (IND) and New Drug Application (NDA) submissions across a wide variety of therapeutic areas. LRA assists clients with their regulatory strategy and is often involved with helping pharma and biotech companies prepare and conduct meetings with the FDA regarding the format and content of these regulatory submissions.

The Challenge
Like the pharma industry itself, the CRO industry is highly competitive. The smaller to mid-sized CROs like LRA must decide which services they are going to develop in-house and which activities are most appropriate to either contract in or refer out to other companies. LRA recognized that its expertise was in the non-clinical, clinical, and regulatory strategic development issues related to regulatory submissions and in the actual medical writing of the required components.

LRA also recognized that it needed to offer its clients an efficient and cost-effective way of handling the compilation and electronic publishing of their regulatory submissions. That was an area that LRA had chosen not to develop internally. Rather, the company elected to identify experts that LRA and its clients could trust to provide this technology.

With LRA's extremely strong reputation for quality work, integrity, and trust, it was critically important to the company that it identify an organization and technology that it could confidently recommend to its clients.

The Solution
Liquent Direct regulatory operations outsourcing services allow LRA to offer an option to its clients that make the compilation and publishing of regulatory submissions efficient from both a time and cost perspective. LRA's clients have elected to contract through LRA for Liquent Direct; in other cases, clients have contracted directly with Liquent. For LRA, Liquent provides a team of experienced professionals who offer not only the technical expertise but also have a good understanding of the regulatory requirements involved in compiling and publishing these submissions. LRA has partnered with Liquent on a number of INDs and NDAs in the past few years.

When LRA uses Liquent Direct for one of its projects, Liquent manages the entire compilation process from beginning to end --from scheduling and costs to logistics and final deliverables. Liquent personnel essentially become members of the LRA/Client Project Team and often provide invaluable input about the submission that facilitates the process and timeline.

LRA prefers that the team from Liquent get involved early in the planning process. LRA's experience has been that Liquent plays a leadership role in meticulously defining what is needed to assure that the compilation and publishing of the submission is done well. In addition, Liquent personnel are up to date on the requirements and expectations of the FDA. For LRA and its clients, Liquent has done an excellent job on all phases of the project, from planning and analysis to report publishing, production, system delivery, and scanning and printing services. LRA has developed a great deal of confidence in Liquent and often recommends Liquent Direct to its clients.

The Results
All of the INDs and NDAs that LRA has completed in collaboration with Liquent have been on time and within budget. Explained Mark Cierpial, Ph.D., LRA's Vice President of Clinical Operations and Regulatory Affairs, "Outsourcing to Liquent is a way to meet the requirements of our sponsors without adding internal staff. It is an excellent way for us to provide a sponsoring company with the service it needs without either LRA or our clients making a major investment in electronic regulatory publishing."

Electronic submissions are associated with the benefits of faster time to market, lower costs, and facilitated review. Much of the time-to-market savings is realized by beginning to prepare and publish the submission well before all the content is finalized -- allowing faster turnaround as last-minute documents are received.

Although more difficult, some of this benefit can be achieved with paper submission formats as well, as long as an electronic compilation process is used. Other cost savings are realized by eliminating the need to print, copy, distribute, and store massive amounts of paper. At up to 1 million pages, regulatory submissions are among the largest publications in the world. Regulatory agencies are thought to benefit as well. During the review cycle, the agencies have the ability to search content and find related or referenced information more quickly and perform direct analyses on raw data.

LRA's first experience with Liquent reinforced its belief that electronic publishing would add value and efficiency. The company was especially pleased with the Liquent Direct option as it allowed the ability to manipulate documents right up until the very end of the submission preparation and assembly process. Dr. Cierpial cites electronic publishing's fast turnaround and compilation features as invaluable to completing submissions within extremely tight time constraints.

Cathy Frieden Lineberry, Executive Vice President of Business Operations & Client Services at LRA, noted that it is not only the technical service that Liquent brings but also the overall knowledge of the regulatory issues involved in electronic publishing that makes the collaboration such a rewarding relationship. "When we are able to bring Liquent into the relationship early in the project, it becomes a very collaborative process. LRA has developed an excellent working relationship with the experienced professionals at Liquent." Concluded Dr. Cierpial, "Liquent brings value to LRA in our dealings with the FDA. Liquent personnel add a high level of credibility through their technical expertise and experience in the market, which in turn provides LRA and our clients additional credibility with the FDA."

For LRA, business continues to be strong and the company continues to grow. The CRO's ability to overcome a stagnant CRO market and volatile pharmaceutical industry is due to its successful strategy of leveraging internal assets with external expertise. In this way, LRA focuses on its core competencies, maintains its phenomenal rate of repeat business, and continues to attract new clients.