Pharmaceutical Document Management


How Effective Pharmaceutical Document Management Helps Companies Accelerate Time to Market

Translating a scientific idea into a safe medicine that benefits millions of people is a long, difficult, and expensive process. Research shows that the development of innovative new medicine is a lengthy, costly, and complex process. On average, research and development for a new drug product is a process of 10 or more years, with the clinical trial component alone taking roughly six to seven years. With only 12 percent of drugs that enter clinical trials actually resulting in an approved medicine, the average research and development cost for each successful drug is estimated at $2.6 billion (including the cost of failures), according to the Pharmaceutical Research and Manufacturers of America (PhRMA). This expensive and difficult process can be accelerated and eased by MasterControl's pharmaceutical document management software solutions, which are expressly designed to meet the regulatory requirements that pertain to pharmaceutical companies' compliance, such as good laboratory practices (GLP). and current good manufacturing processes (cGMP).

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Here's how the drug research, development, and patent process typically unfolds: A company obtains a 20-year patent for its new drug at the start of the discovery process. It takes 11 years on average for a company to develop the drug and get it approved by the FDA. Taking out 11 years of development time from the 20-year period of exclusivity under the patent leaves a company just nine years to capture the full value of its product before generic competitors enter the market. In addition, a company loses 75 percent of its pre-generic sales in the first year that competition enters the market, according to an article by Josef Bossart, founder and principal of Bossart4 Bioconsult, in the July-August 2006 issue of Specialty Pharma. And the loss is estimated to increase to 85 percent in the second year, and 90 percent beyond that. The graphic below shows the typical timeline for drug discovery and development and illustrates how pharmaceutical document management software fits into each phase of the process and can help companies avoid or minimize the aforementioned losses.

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Needless to say, the period of exclusivity for a new drug is critical. Any delay that cuts this time span could cost the company millions, depending on the size of the company and the time and money invested in the product. In the drug development process, time is indeed money. So it only makes sense to try to reduce delays in every phase of the process by streamlining pharmaceutical document management. But how and where do you begin to save time?

TThe fact is, drug development requires document-intensive work. It behooves a pharmaceutical, biotechnology, and in some cases a medical device company or a contract research organization (CRO) to start with a basic activity that must be performed throughout the drug development cycle: document management. From the scientists leading the drug discovery process to the marketing specialists writing a new drug's labeling—they all need to document their activities for a variety of reasons. More importantly, they need to efficiently manage and control their documents because any delay caused by poor pharmaceutical document management could affect overall time to market.

Preclinical Phase of Pharmaceutical Document Management

The years spent by chemists, biologists, pharmacologists, toxicologists, and other scientists "discovering" the right combination of chemical and biological substances that could be used for a drug are geared toward the submission an investigational new drug (IND) application. FDA approval of the IND is necessary to conduct clinical trials and to proceed with product development. MasterControl's software solutions expedite pharmaceutical document management processes and allow companies to organize and execute IND submissions to the FDA as rapidly as possible and according to regulatory guidelines.

Discovery research scientists typically start with thousands of possible compounds. Through continuous testing, screening, and refining that could take several years, they would whittle down the thousands of compounds to hundreds, and then dozens, and then three to five drug "candidates" which can be achieved in less time with a pharmaceutical document management system. This rigorous phase includes laboratory and animal studies that cover chemistry tests, biological tests, manufacturing tests, and pharmaceutical development studies. The overarching goal during this phase is to determine the safety of the candidates before they are tested in people.

Thousands of documents are generated during the preclinical phase. The IND submission alone requires the compilation of everything known about the new drug being developed: its chemical structure; how it might work in the human body; how it works in animals; any side effects in animals; and how the compound is manufactured. The IND also must include detailed information on how the company plans to test the drug on humans during clinical trials. To help companies better manage those documents, MasterControl offers the leading pharmaceutical document management software on the market.

Pharmaceutical, biotech, and medical device companies and the CROs that serve them need effective document management during this phase for two major reasons that directly affect time to market:

  • Efficiency: Thousands of documents generated in pharmaceutical companies over a period of one or more years necessitate a formal pharmaceutical document management process to ensure that documents are not lost, and that details of the research can be tracked, retrieved, revised, recreated (if needed) and approved easily. Without an efficient system for managing documents, thousands of man-hours will be spent on even the simplest tasks.

  • Compliance: FDA regulations such as 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) and 21 CFR Part 312 (Investigational New Drug Application) require effective pharmaceutical document management. The 21 CFR 58 guideline has specific document control requirements pertaining to SOPs for animal care, lab tests, data handling, and equipment maintenance and calibration; protocols; and handling of records, reports, and raw data documentation. And 21 CFR 312 has its own set of requirements pertaining to recordkeeping, record retention, and investigator reports. Management of IND documentation is particularly crucial because it serves as the basis for other information that will be submitted to the FDA later.

Pharmaceutical Document Management Clinical Phase

While preclinical work is directed toward the IND submission, the clinical phase is geared toward the submission of an equally important regulatory filing: the new drug application (NDA).

Clinical studies on average extend 10 years or longer, with documents generated from various parties such as the sponsor, CROs supporting aspects of the study, and clinical study sites participating in the study and patient enrollment. The collection of these documents ultimately make up the clinical study’s Trial Master File (TMF), a compilation of all information regarding how the study was conducted. Clinical studies are a pivotal aspect of establishing the safety and efficacy of a product during research and development as each study phase progresses. Once the clinical studies providing proof of safety and efficacy are complete, a sponsor must organize all the content and data and submit the supporting documentation in a marketing application. In the US, this comes in the form of an NDA for pharmaceutical drugs or a biologic licensing agreement (BLA) for biologics. In other countries a Marketing Authorization Application (MAA) or other applications may be filed to appropriate regulatory bodies, many times in the form of an electronic Common Technical Document (eCTD).

For more information about these regulations and the processes and tools that compliance entails, visit MasterControl’s eTMF software systems and EDM JumpStart pages.

As in the preclinical phase, if not more so, the clinical stage requires effective pharmaceutical document management to help achieve:

  • Efficiency: Managing hundreds of thousands of documents generated by cross-functional teams during a period of 10 years or more is a daunting challenge. Bottlenecks abound during this phase because there are more people involved in the process and the data from clinical investigators grow exponentially from Phase I through Phase III and IV. These pains can be eased by MasterControl's pharmaceutical document management software.

  • Compliance: : In addition to GLP and GCP requirements that various teams must comply with, the sponsor also must manufacture the investigational new drug used for clinical trials in accordance with Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Parts 210-211. GCP also includes guidances that call for effective pharmaceutical document management. Moreover, the sponsor must comply with 21 CFR Part 314 (Applications for FDA Approval to Market a New Drug) for its NDA submission. MasterControl's pharmaceutical document management software solutions are designed to help companies meet these compliance requirements.

Commercialization, Product Launch, and Post-Market Phase of Pharmaceutical Document Management

While a sponsor awaits approval from the regulatory agency (i.e., FDA), it is likely to be gearing up for mass production, or perhaps it is already manufacturing the drug. Regulatory approval takes 18 months on the average, according to PhRMA. As soon as the FDA approves the NDA, the company will be able to start marketing and selling the new drug. Even after the product approved and brought to the market, the communications with regulatory authorities regarding the product do not end. Sponsors continually submit amendments to regulatory agencies with information regarding manufacturing changes, adverse event reports, and annual reports. All of this documentation can easily be managed inside of MasterControl's pharmaceutical document management system.

With the clock ticking in terms of market exclusivity, a company that has just launched a new drug needs effective pharmaceutical document management to help achieve:

  • Efficiency: After regulatory approval, pharmaceutical document management needs are especially great in the areas of quality control, manufacturing, marketing, and sales. Volumes of documents will be generated by quality-related processes for handling corrective and preventive actions (CAPA), electronic batch records (EBR), consumer complaints, adverse event reports, quality audits, deviations, and nonconformances, among others.

  • Compliance: Document management is a GxP requirement and MasterControl's pharmaceutical document management solutions ensure compliance with regulatory guidelines. In addition, the pharmaceutical or biotech company with a newly approved NDA must address post-market requirements found in 21 CFR Part 314, including the reporting of adverse drug experiences and the submission of NDA field alert report, as well as annual reports, distribution data, labeling, reports on CMC changes, and so forth.

Learn more about MasterControl's GMP document control functionality here.

The MasterControl Pharmaceutical Document Management Solution

MasterControl pharmaceutical document management software provides a solid foundation for effective document control and helps accelerate overall time to market by simplifying workflows, promoting efficiency, and making compliance easier. Below are some of the benefits of using MasterControl throughout the drug development process.

Increased Efficiency Through Automation. MasterControl's pharmaceutical document management system reduces document cycle time and simplifies document management by automating routing, notification and follow-up, escalation, and approval of a pharmaceutical company’s documents. Its robust tracking feature identifies bottlenecks by showing when a document was sent and to whom. It shows a document's history, including who has approved it and when. A document that has been rejected will automatically go back to the sender, so tasks don't languish. MasterControl can handle all types of documents, regardless of the software used to create them.

Centralized Repository Makes Search and Retrieval Easier. You can store all records and documents from the discovery stage through the post-market phase in a centralized electronic repository like MasterControl’s pharmaceutical document management system, making it easier to update, and to search and retrieve them. Documents reside in secure virtual vaults that can be accessed only by authorized users. Access is limited by the extent of a user's system rights. Although the system is centralized, every department can compile documents separately using MasterControl tools that operate in similar fashion to Windows Explorer and help users find documents quickly.

Web-Based Platform Provides Easy Access. A web-based system for pharmaceutical document management gives employees in different locations and time zones easy access at any time. Even CROs, suppliers, consultants, and other authorized third-party users outside of the company can have system access based on the extent of their roles in any document-based process.

Automatic Revision Control Reduces User Mistakes. With a paper-based document control process, there is no mechanism to stop a user from inadvertently using obsolete or unapproved documents. With MasterControl's pharmaceutical document management software, revision control is automatic, so only approved documents are released. Any outdated documents are automatically archived, and documents in the process of revision are locked. The system provides a time-stamped audit trail of all changes made to a document.

Virtual Workspace Makes Collaboration Easier. Collaboration is possible regardless of location through a virtual workspace that enables cross-functional reviews and approvals of documents. MasterControl’s pharmaceutical document management system automates tasks pertaining to collaborative projects, including routing, follow-up, escalation, and approval.

Best Practices Help Streamline Workflows.To increase efficiency, MasterControl incorporates best practices for pharmaceutical document management in critical processes such as CAPA, nonconformance disposition, deviation handling, EBR management, quality audit, change control, or any document-based or forms-based process. Best-practice workflows can be used as is or reconfigured.

Electronic Approval Fosters Efficiency.MasterControl’s pharmaceutical document management system has the capability to review and approve documents electronically, which speeds up the approval process significantly. Signature manifestation can be appended automatically to each document as required by 21 CFR Part 11. In addition to e-signature, the system provides a time-stamped audit trail that can be linked to the approval process.

Integrated Approach Connects Document Control with Other Processes. MasterControl connects document control processes with other quality processes for complete pharmaceutical document management, and it synchronizes changes in documents and documented processes. For example, document control can be integrated with customer complaints, CAPA, and training control processes. So a customer complaint serious enough to require a CAPA will be automatically escalated to the CAPA process, if desired. Any document change resulting from an approved CAPA can be set to automatically trigger training on the revised document for all affected employees.

Integration Helps Optimize E-Submission Process. MasterControl can be integrated with leading e-submission tools to optimize and accelerate the electronic submission process. MasterControl's pharmaceutical document management system provides a single repository for all regulatory submissions, as well as a virtual workspace where different teams can easily and quickly revise the dossier.

Integration Helps Leverage Existing Systems. You can leverage your existing systems, such as ERP, PDM, and PLM, by integrating them with robust MasterControl's pharmaceutical document management applications without expensive custom coding.

Risk-Based Software Validation Offerings Help Reduce Compliance Burden. MasterControl offers a line of products and services designed to dramatically reduce the time, pain, and cost involved in software validation. Companies may choose the appropriate products and services based on their own risk assessment.

Flexible Approach Makes System Ownership More Cost-Effective. While mature companies typically prefer to purchase a full MasterControl pharmaceutical document management platform outright, many smaller companies choose the small-business focused MasterControl Spark offering for a minimal upfront cost. This approach allows fast deployment, offers software validation services, and requires no technical maintenance or special equipment but has the scalability to grow with the company. As needs grow, a company may want more configurability and additional software modules (i.e., CAPA, change control, training management, etc.) to fit new requirements.

Learn More About MasterControl's Pharmaceutical Document Management Software

To learn more about the pharmaceutical document management system from MasterControl, as well as the related quality processes the connected MasterControl platform is able to streamline, please feel free to contact a MasterControl representative.