Web Document Management During Preclinical and Clinical Phases of Pharmaceutical/Biotech Development
Marci L. Crane
February 13, 2009
The preclinical and clinical phases of drug development are obviously essential to the realization of a successful pharmaceutical. However, for many small and mid-sized pharmaceutical companies these phases are especially crucial since drug pipelines (at this stage of development) are either meager or immature. In short, these companies haven't reached the "tipping point" of success, which in the pharmaceutical industry unfortunately often comes later rather than sooner.
What can Small and Mid-Sized Companies do?
Small and mid-sized companies can take steps forward to make their companies more competitive within the industry. Investing in solutions that will streamline the management and control of GCP documentation (i.e., web document management solutions) and any and all extraneous document types will not only allow phases of preclinical and clinical development to progress without a significant amount of tedious administrative work (e.g., filing, manual documentation routing, searching for lost documentation, etc.), but with the right web document management solution, will also allow small and mid-sized companies to build a solid foundation that will allow for the integration (over time) of electronic collaboration, learning management, business process management, full-scale quality management and product lifecycle management systems.
Where to Start?
Small to mid-sized pharmaceutical companies should start looking for a web document management system not by asking for referrals (not yet!) but by sitting down and writing out a list of URS (user requirements specifications). Once these are listed and approved, then it is time to find out what small, mid-sized and large pharmaceutical corporations are using in their respective environments. Many companies will only use management technologies for a short 10-15 years so it is important to notice how long these companies have been utilizing their current systems and whether or not their respective software vendors provide annual software upgrades and significant advancements in product development. A history of effective product development should be backed by at least three solid referrals.
Once your company has these referrals, approach the vendor and ask them what they can do to meet your user requirements specifications and whether or not they have an expert(s) on staff who have worked within the pharmaceutical industry and is current with the ever-changing needs of the life science sector---especially the drug industry. If they meet these standards, ask them if they can host the solution at their own site. This can save small to mid-sized companies hundreds of thousands of dollars of upfront costs. However, make sure that the ASP offering (i.e., SasS offering) is also transferable to an in-house system as you prefer to house the system as your own company grows and develops.
Other Considerations
It can also be nice (and sometimes necessary), depending on your user requirement specifications if the web document management solution provides these features/benefits:
Conclusion
It seems inevitable that pharmaceutical companies of all sizes must move in the direction of sleeker manufacturing processes (e.g., leaning manufacturing, Six Sigma) and more effective technology enablers. This entire process can start with a web document management solution.
Marci Crane is a marketing communication specialist for MasterControl in Salt Lake City, Utah. To learn more about web document management and MasterControl's GCPDocs Express document management software designed especially for small to mid-sized pharmaceutical companies, please feel free to contact a MasterControl representative.
What can Small and Mid-Sized Companies do?
Small and mid-sized companies can take steps forward to make their companies more competitive within the industry. Investing in solutions that will streamline the management and control of GCP documentation (i.e., web document management solutions) and any and all extraneous document types will not only allow phases of preclinical and clinical development to progress without a significant amount of tedious administrative work (e.g., filing, manual documentation routing, searching for lost documentation, etc.), but with the right web document management solution, will also allow small and mid-sized companies to build a solid foundation that will allow for the integration (over time) of electronic collaboration, learning management, business process management, full-scale quality management and product lifecycle management systems.
Where to Start?
Small to mid-sized pharmaceutical companies should start looking for a web document management system not by asking for referrals (not yet!) but by sitting down and writing out a list of URS (user requirements specifications). Once these are listed and approved, then it is time to find out what small, mid-sized and large pharmaceutical corporations are using in their respective environments. Many companies will only use management technologies for a short 10-15 years so it is important to notice how long these companies have been utilizing their current systems and whether or not their respective software vendors provide annual software upgrades and significant advancements in product development. A history of effective product development should be backed by at least three solid referrals.
Once your company has these referrals, approach the vendor and ask them what they can do to meet your user requirements specifications and whether or not they have an expert(s) on staff who have worked within the pharmaceutical industry and is current with the ever-changing needs of the life science sector---especially the drug industry. If they meet these standards, ask them if they can host the solution at their own site. This can save small to mid-sized companies hundreds of thousands of dollars of upfront costs. However, make sure that the ASP offering (i.e., SasS offering) is also transferable to an in-house system as you prefer to house the system as your own company grows and develops.
Other Considerations
It can also be nice (and sometimes necessary), depending on your user requirement specifications if the web document management solution provides these features/benefits:
- Top-to-Bottom Version Control;
- Web-Based, Centralized System for Documentation Archival;
- Advanced Reporting Features;
- The Option to Combine the Solution with Collaboration and Training Capabilities;
- 21 CFR Part 11 Compliant Features such as Electronic Approval Requirements;
- Provides Data Collection Automation;
- Automated Routing of Documentation;
- Automated Follow-Ups;
- Automated Escalations of Approval Processes and Document Review
Conclusion
It seems inevitable that pharmaceutical companies of all sizes must move in the direction of sleeker manufacturing processes (e.g., leaning manufacturing, Six Sigma) and more effective technology enablers. This entire process can start with a web document management solution.
Marci Crane is a marketing communication specialist for MasterControl in Salt Lake City, Utah. To learn more about web document management and MasterControl's GCPDocs Express document management software designed especially for small to mid-sized pharmaceutical companies, please feel free to contact a MasterControl representative.