Regulatory advancements can reduce drug development timeline

By Mary Ann Scott, Senior Director of Regulatory Operations at MPI Research

Regulatory Operations at MPI Research is composed of a diverse and complex group of professionals dedicated to excellence in a variety of areas. Key departmental functions include Quality Assurance, Systems Compliance, Regulatory Services, Metrology, Submission Services, Biostatistics, Information Technology, and Safety, Environmental, and Health Services. Mary Ann Scott, Senior Director of Regulatory Operations at the company has agreed to field a number of questions about the standards and precedents that MPI Research is setting in this field.

1)     What is MPI Research doing to help shorten drug development timelines?

MPI Research is moving ahead in the industry by offering full service capabilities and investing in cutting-edge technology which allows for greater automation and the shortening of timelines. As part of our commitment to producing a quality product that will assist Sponsors in reducing their timelines to regulatory submission, MPI Research is introducing new industry-leading technologies.

2)     In what technology is MPI Research investing?

The Provantis 8^TM data collection system went live at MPI Research in December 2008. This system offers several advantages, including improved methods of test material administration verification, an extended range of randomization types, customized clinical pathology worksheets, streamlined reproductive toxicology and fetal pathology data collection, and enhanced raw data reports. MPI Research also introduced a new reporting system in December 2008; the Table Production System (TPS).

The Table Production System (TPS) is the first nonclinical reporting system to utilize BusinessObjects, an integrated data warehouse/business intelligence tool. This allows the creation of on-demand, high quality, preclinical data tables and figures with a comprehensive statistical analysis suite. This approach will allow for data mining for historical control reporting and the integration of data collected in different source systems onto a single table.

3)     What kind of record does MPI Research have for report delivery?

MPI Research is committed to making sure that Sponsor milestones are met, and this includes delivery of high quality, submission-ready study reports. In addition, we deliver CTD tabulated summaries, and data transport files to Sponsors for regulatory submissions. Over the past six years, MPI Research has delivered 98% of reports on-time and 80% early to our Sponsors.

4)     That takes care of the reporting, but does MPI Research offer publishing services?

MPI Research utilizes docuBridge®, a submission publishing system, to compile the nonclinical reports, which is the same technology utilized to create full IND and NDA submissions. ISIToolBox, in conjunction with docuBridge, allows MPI Research to provide our Sponsors with an unparalleled level of nonclinical report publishing. This suite of tools gives MPI Research the ability to provide publishing support to our Sponsors on projects as small as a single report through the complexity of an entire regulatory submission.

5)     Are all of these software programs validated?

Provantis 8, TPS, and docuBridge are fully validated under the MPI Research state-of-the-art validation master plan. These systems underwent a rigorous process to ensure compliance with the requirements of 21 CFR Part 11 and Part 58 and are subjected to a biannual system review to assure continued compliance.

6)     Can you describe how the Quality Assurance Unit is structured and how the Quality Assurance group works to ensure high quality research at MPI Research?

There are two Quality Assurance functions, Quality Assurance Research and Quality Assurance Compliance. The two functions allow our Quality Assurance group as a whole to focus both on study specific auditing and facility level auditing.

Quality Assurance Research auditing is focused on study conduct, data and reporting. With knowledge of several Good Laboratory Practice (GLP) regulations, the Quality Assurance Research department assures compliance with GLPs, study protocols and SOPs. Quality Assurance Research also conducts audits of subcontracted facilities to assure multi-site compliance.

Years of experience within the Quality Assurance Research staff range up to 14 years, with an average of four years in GLP auditing. The majority of the auditing staff also maintain RQAP-GLP certification.

Quality Assurance Compliance auditing functions focus on processes and records compliance across the company, targeting all departments and quality systems peripheral to the conduct and support of study work. These audits include comprehensive facility inspections; computerized systems validation audits; system reviews, which are periodic reviews of validated computerized systems in production; equipment qualification audits; and software development audits. Additionally, Quality Assurance Compliance conducts vendor audits and partners with the Quality Assurance Research department on subcontractor inspections.

Perhaps the most innovative function of Quality Assurance Compliance is the Significant Deviation Investigations; our version of CAPA. The internal auditors are assigned investigations by management for recurring or critical deviations determined to have a significant impact on conduct of study activities. Working with department management, corrective actions are put in place and monitored by the auditors for effectiveness. We are pleased to announce that MPI Research is integrating Lean Six Sigma capabilities into this investigation process this year.

Years of experience within the Quality Assurance Compliance staff range up to 18 years, with an average of four years in GLP auditing. Senior auditing staff also maintain RQAP-GLP certification.

7)     How often is MPI Research audited? What has the inspection record of MPI Research been?

MPI Research has a remarkable record for compliance with federal regulations. In the past 11 years, MPI Research has been inspected by the FDA over 10 times and over 50% of these inspections have resulted in zero FDA 483 observations. MPI Research is also routinely audited by our Sponsors and potential Sponsors.

8)     Is MPI Research involved with SEND?

MPI Research plays a leadership role in industry regulatory initiatives. For example, as an active participant in the SEND (Standard Exchange for Nonclinical Data) project, the company is partnering with one of our Sponsors on the FDA SEND pilot. This involves the utilization of MPI Research technical expertise and an investment in data collection and reporting technologies to design a system to efficiently create compliant data sets.

9)     What is the approach MPI Research is taking to offer integrated services?

MPI Research is committed to partnering with Sponsors to get drugs to the market faster. As a part of this commitment, MPI Research has invested in innovative data collection, reporting, and publishing systems to support the needs of biotech and large pharmaceutical companies by efficiently delivering products of the highest quality. In addition to these services, MPI Research is pleased to announce that we offer consultation on study design and program management. We also offer a full-range of preclinical and early clinical discovery, toxicology, and analytical services.

A full service Contract Research Organization, MPI Research serves the biopharmaceutical and biotechnology industry in meeting their preclinical/early clinical drug development needs. Contact us at maryann.scott@mpiresearch.com or +1.269.668.3336 to learn more about how our regulatory technology can expedite moving your research programs forward.

Mary Ann Scott is the Senior Director of Regulatory Operations at MPI Research. In this capacity, she oversees Quality Assurance, Systems Compliance, Regulatory Services, Metrology, Submission Services, Biostatistics, Information Technology and Safety, Environmental and Health Services. Ms. Scott has been with the company since 1994 and has held various management positions. Ms. Scott holds a BS from Grand Valley State University and is an active member of the Society of Quality Assurance (SQA), the Drug Information Association (DIA).