It takes, on average, 12 years and millions of dollars for an experimental drug to travel from lab to medicine chest and only five in 5,000 compounds that enter pre-clinical testing make it to human testing. You face increasing demands to control R&D costs, shorten drug development times, deliver more drugs to market and build shareholder value. You must do all this and comply with stringent regulatory requirements. Perhaps no other industry has more intensive document management requirements. To succeed in this environment, you need a records management partner with the knowledge and methodologies to help you accelerate the drug development process and ensure compliance.
Jeter Can Help
For over 30 years we have been providing major pharmaceutical companies with expert advice to ensure their records systems are compliant, efficient and effective.
Jeter records management professionals will benchmark your document management practices against best in class systems. We will apply our expertise to the development of a document management solution that fits your organization, allowing your scarce and highly skilled scientific staff to focus on drug development.
Work More Efficiently
Research and laboratory notes are the means by which your research efforts and results are communicated, coordinated and evaluated. New drug submissions are vital to the launching of new products. Quality assurance records (production, stability, batch sampling) provide the “corporate memory” of quality assurance activities. By developing and implementing a records management system for your organization Jeter will help you ensure the efficient and accurate management of documents throughout the entire development process. Classification and retention schedules are developed, active documents are organized, controlled and retrieved utilizing supplies and software that identifies their location at all times. Storage solutions protect the integrity and security of all documentation, while maximizing available workspace in development laboratories. Knowledge is organized allowing information to be shared and you to make better business decisions.
Demonstrate Regulatory Compliance
Testing, phased clinical studies, trademark and patent applications and intellectual property rights are key elements to the development of pharmaceuticals. With millions of dollars at stake, strict compliance with all regulatory, product safety, privacy and corporate governance requirements is essential. A clearly defined records management program will outline your responsibilities in creating, maintaining, and retaining critical records, It will also provide the policies and procedures to your staff to ensure that you are meeting your legal obligations.
For more information on how Jeter can help your organization with pharmaceutical records management, call 1-877-252-0220 or complete our online response form.