In recent years the Life Sciences industry has seen many product recalls and withdrawals from market due to safety concerns from patients and the resultant actions by regulators. Pharmacovigilance has become a more proactive process as opposed to a more reactionary process in the past.
Electronic data collection and submission of Adverse Events (AEs) in recent years has enabled organizations to collect huge data sets of safety information. Some pharmaceutical organizations have invested heavily on building or procuring IT systems that can analyze these datasets and produce safety observations that have the potential to become signals. This method of applying mathematical / scientific statistical algorithms to identify potential signals is termed as ‘Quantitative Signal Detection’. Another way of identifying safety observations is the manual process of reviewing all cases being reported, by a medical professional, to identify potential signals. This process is termed as ‘Qualitative Signal Detection’. Many small to medium organizations employ this method of detecting potential signals. More than the size, it is the volume of cases that need to be analyzed that would be a key criterion for organizations leaning one way or the other. Some organizations may also employ a hybrid model i.e. quantitative analysis followed by qualitative analysis.
Microsoft SharePoint is a very popular collaboration and content management platform adopted by many organizations across the globe. Life Sciences organizations are no exception to this trend. In recent years SharePoint has seen rapid growth in even areas that require more cautious adoption of new technology due to the impending regulatory requirements (e.g. 21 CFR Part 11 compliance). However, due to the efforts from Microsoft as well as other IT and Life Sciences organizations SharePoint is being adopted in areas where it requires validation.
Signal Management, the process that ensues once the Signals are detected using one of the two methods i.e. Qualitative or Quantitative Signal Detection, is the process where the information related to a safety observation and the corresponding cases that lead to the observation are reviewed by professionals and scientists and decision is made on whether the signal is refuted or verified (other states are also possible). The information is usually captured in forms and passes on from one state to another following a specific workflow with associated service levels for each step in the process. This yields itself as a potential candidate for automation. SharePoint natively supports configuration of forms, management of documents as well as simple workflows. As mentioned above, many organizations have already made investments in SharePoint and hence will be able to save costs by leveraging this tool for Signal Management automation.
Update on 02/15/2012: Please refer to an article by me, on this topic, published by “Drug Safety Directions” here: Signal Management using SharePoint
I was asked to provide inputs to help in the decision-making process by a customer of ours who were trying to figure out if they should leverage native SharePoint for their Regulatory Document Management or look for a Commercial-Off-The-Shelf (COTS) package built on top of SharePoint. I have given 5 reasons from my list, below:
1. Customization Vs Configuration
SharePoint, implemented as a Document Management System would provide the ability to store and retrieve documents along with other features like version control etc. However, in order to leverage it for regulatory document management a lot of customization is required in terms of workflow, terminology, metadata, reports etc. In contrast a COTS system comes with flexible, predefined workflow and other features required for regulatory document management system of a Life Sciences organization’s requirement.
2. Rapid Implementation
Traditional SharePoint roll-out may take months to implement and configure it for regulatory requirements like 21 CFR Part 11, Electronic/Digital Signatures etc. On top of that, customization of SharePoint is required to adopt it for regulatory document management. A COTS system implementation is typically completed much faster including validation of the system to comply with regulatory requirements such as 21 CFR part 11.
3. Electronic Signatures, Audit Trail and 21 CFR Part 11 compliance:
Most COTS systems are available with e-signatures that are required as part of 21 CFR Part 11 compliance. A regular SharePoint implementation demands additional effort to be spent to configure this feature such that it is applicable to regulatory document management. The COTS systems also provide audit trail feature which is then leveraged in reporting and assists in audit process.
4. Metadata and Terminology
Meaningful metadata is the key to be able to search and retrieve documents easily. Also, the metadata needs to have fields that are domain specific rather than generic. Traditional SharePoint implementation does not define the metadata required to store regulatory documents whereas most COTS Regulated DMS’ come with predefined metadata for regulatory document management and also has provision to configure these based on organizational requirements.
5. Reports and Audit
Most COTS systems provides reporting capability out of the box. However, these reports are not available in standard SharePoint implementation.
While Cost, Vendor Dependency etc. could be reasons why customers might want to use SharePoint out-of-the-box with some configuration, it will never be the same as a purposefully designed and developed commercial system. As always, feedback and comments are welcome.
Implementing FDA REMS Elements to Assure Safe Use (ETASU) Requirements using a Business Process Management Suite(BPMS)
It is essential that all new products developed and marketed by bio-pharma and device companies are safe to use and fulfill their efficacy requirements. However, it has been our practical experience over many decades that in most cases there are certain unwanted side effects. Hence, to ensure that the benefits outweigh the risks, regulators have been approving certain drugs under strict risk management assurances from the license holders.
In the US, the Federal Drug Administration (FDA) has been trying to address this through various regulations for over five years through Risk Management Action Plans (RiskMAP) and Risk Evaluation and Mitigation Strategies (REMS). The most recent guidance on this subject was issued in September 2009 through “Guidance for Industry Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications”. In this guidance one of the important REMS elements that may be required is “Elements to Assure Safe Use”.
As part of this requirement the NDA/BLA applicants have to take measures to provide safe access for patients to drugs with known serious risks that would otherwise be unavailable. If a product is assessed to fulfill ETASU requirements then the sponsors are required to train and certify health care providers, pharmacies, patients and drugs. The drugs may be released to patients in a controlled manner only upon receiving evidence of their lab results. The sponsors may also have to register the patients and might subject them to certain monitoring as well. In a few cases the sponsor may be asked to extend the certification process to wholesalers, distributers etc. as well.
In order to fulfill the above mentioned requirements sponsors typically set out to build new IT systems. This is a challenging task as there is a possibility that these requirements could change over time and also there aren’t any commercial off the shelf products available in the market to address the specific REMS ETASU requirements.
To overcome this challenge, sponsors can look up to a Business Process Management System (BPMS) that is precisely built to handle such scenarios. Many other industries have successfully used BPMS to meet their ever changing requirements and priorities by integrating their business processes based on rules. Many commercially available BPMS systems typically include a process engine, Business Analytics, Content Management and Collaboration tools. These BPMS system building blocks can be effectively leveraged to fulfill the ETASU requirements by effectively providing features like Rules management, Content Management, Training Management, Patient/Provider/Pharmacy Registries, Collaboration Portal/Website, IVR/IWR, 21 CFR Part 11 compliance, Audits and integration with other enterprise applications.
My Article on the same topic is published on “Drug Safety Directions” Website. You can access the article here: “Implementing FDA REMS Elements to Assure Safe Use (ETASU) Requirements using a Business Process Management Suite“.