Let's take the hypothetical example of a young pharmaceutical company with one product so far. The company obtained a 20-year patent for its new drug at the start of the discovery process. Let's say it took 11 years for the 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 would leave the company only nine years to capture the full value of its product before generic competitors enter the market. A company loses 75 percent of its pre-generic sales in the first year that competition enters the market, according to Josef Bossart, founder and principal of Bossart4 Bioconsult, in an article in the July-August 2006 issue of Specialty Pharma. The loss is estimated to increase to 85 percent in the second year, and 90 percent beyond that which can be minimized or eliminated by pharmaceutical document management software.
Needless to say, the period of exclusivity for a new drug is critical. Any delay that cuts this period could cost the company a lot. In the drug development process with ordi, time is indeed money. So it only makes sense to try to reduce delays in every phase of the process by existing pharmaceutical document management. But how and where do you begin to save time?
The fact is, drug development requires document-intensive work. It behooves a pharmaceutical or biotechnology 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 control or manage their documents. So any delay caused by poor pharmaceutical document management could affect overall time to market.
This white paper will discuss common challenges pertaining to document control encountered by most drug companies from the preclinical stage through the post-market phase, and how the MasterControl™ GxP process and pharmaceutical document management software solution addresses such challenges.
Preclinical Phase of Pharmaceutical Document Management
One could say that 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. MaterControl's pharmaceutical document management system provides fast pace documentation processes & document delivery to FDA for approval.
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.
The preclinical phase could easily generate thousands of documents and to manage those documents MasterCOntrol offers pharmaceutical document management software. 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.
Pharmaceutical and biotech companies and the CROs that serve them need effective document control 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 to three or more years necessitate a formal pharmaceutical document management process to ensure that documents are not lost, and that they can be tracked, retrieved, revised, and approved easily. Without an efficient system for managing documents, thousands of man-hours will be spent in 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) requires effective pharmaceutical document management. 21 CFR 58 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. 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).
During this stage of pharmaceutical document management, doctors (called clinical investigators) carry out studies to find out if the drug is safe in people and whether it is effective in treating the targeted disease. There are three phases in every clinical trial: Phase I (the drug is tested in 20 to 100 healthy volunteers), Phase II (involving 100 to 500 volunteers who have the disease that the new drug is meant to treat), and Phase III (involving 1,000 to 5,000 volunteer patients).
Clinical trials could take up to 10 years & MasterControl's pharmaceutical document management system can store all documentation done within & beyond 10 years, during which the sponsor will conduct parallel research on toxicity, dosage forms, and methods for full-scale manufacturing and packaging of the drug. Everything about the clinical phase is geared toward the NDA submission, which essentially summarizes 10 or more years of development work. The NDA dossier is complex and voluminous - anywhere from 100,000 to 600,000 pages of text that are meant to persuade the FDA to approve the new drug.
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 and can be managed by MasterControl's pharmaceutical document management software. 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.
- 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 guidance 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.
Commercialization, Product Launch, and Post-Market Phase of Pharmaceutical Document Management
While a sponsor is waiting for FDA approval, it is likely to be gearing up for mass production, or perhaps it is already manufacturing the drug. FDA 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 selling the new drug. But even after the product is brought to the market, the company will continue to submit reports to the FDA which can be easily sent from MasterControl's pharmaceutical document management system, such as adverse reaction reports and quality-control records. In some cases, the FDA may require a sponsor to conduct Phase IV clinical trials to evaluate the drug's long-term effects.
With the clock ticking in terms of market exclusivity, the company that has just launched a new drug needs effective document management to help achieve:
- Efficiency: Document control needs after FDA approval are especially great in the areas of quality control, manufacturing, marketing, and sales which can be effectively managed from a pharmaceutical document management system. Voluminous documents will be generated by quality-related processes that will handle corrective and preventive action (CAPA), electronic batch records (EBR), consumer complaints and adverse event reports, quality audit, deviations, and nonconformance, among others.
- Compliance: Document control is a CGMP requirement and MasterControl's pharmaceutical document management ensures compliance with the regulations. 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, annual report, distribution data, labeling, report on CMC changes, etc.
The MasterControl Pharmaceutical Document Management Solution
The MasterControl™ GxP process and pharmaceutical document management software provides a solid foundation for effective document control that will help 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 reduces document cycle time and simplifies document management by automating routing, notification and follow-up, escalation, and approval for pharmaceutical companies. Its robust tracking feature identifies bottlenecks by showing when a document was sent and to whom. It shows the 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 our 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 the Organizer, a MasterControl tool similar to Windows Explorer, which helps users find documents quickly.
Web-Based Platform Provides Easy Access. A Web-based system for pharmaceutical document management will give employees in different locations and time zones easy access. Even CROs, suppliers, consultants, and other authorized 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 that would 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 for cross-functional review and approval of documents. The 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 customized.
Electronic Approval Fosters Efficiency. The 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 the document control process with other processes for 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. Any document change resulting from an approved CAPA will 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's pharmaceutical document management suite outright, many smaller companies choose the application server provider (ASP) service for a minimal upfront cost. This approach allows fast deployment, offers software validation services, and requires no technical maintenance or special equipment. Companies may select an ASP system that is purely document management and 100 percent preconfigured. Or, as their needs grow, they may want more customization and additional applications (CAPA, change control, training control, etc.) to fit their requirements.
Conclusion of MasterControl's Pharmaceutical Document Management
Time is a precious commodity for everyone, but especially for people involved in drug development. You can maximize development time starting with the way you control document-based processes. As this white paper has shown you, a delay in time to market due to poor document management is largely preventable with the help of the right solution.
To Learn More About MasterControl's Pharmaceutical Document Management Software
To learn more about the pharmaceutical document management system from MasterControl, as well as the solutions they connect with to streamline all of a company's operations, please feel free to contact a MasterControl representative.