Archive | Validation & Verification RSS for this section

Risk based monitoring and SDV – Increased adoption of ECM

It is universal fact that the escalating costs of discovering new medicinal products are driving sponsors and CROs to scrutinize every dollar spent in the process. The situation is escalating fast as pressure mounts with the blockbusters of yester years come off patents. This means that there is a need for all the stakeholders in the value chain to revisit their approach to existing processes and come up with innovative ways to save costs.

Key Trends:

Risk Based Site Monitoring:

US FDA has also recognized this fact and come out with a “Guidance for Industry Oversight of Clinical Trial Investigations – A Risk Based Approach to Monitoring”. As per this guidance the objective of the guidance is “to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof”. As per the document its overarching goal is to “enhance human subject protection and the quality of clinical trial data”. However, it clarifies on the strict interpretation that the industry has assumed long back and has spent billions in monitoring the sites. While this is draft guidance it is more than likely that this will end up in establishing the guiding principles for central monitoring of clinical trials, as such is the intent.

Risk Based Source Document Verification:

Primary activity of site monitoring is the source document verification and as was the case in site monitoring, industry has been mostly using the strict interpretation of source document verification. This resulted in 100% of source documents (patient eCRFs) being verified by the site monitors. However, the industry has realized that “law of diminishing returns” applies to this process as well and has been reducing the percentage of documents verified by the monitors. Medidata’s Insights “Targeted Site Monitoring Trend Snapshot” published in Applied Clinical Trials website confirms this trend.  According to this report the SDV percentage has reduced from 85% in 2007 to 67% in 2010.

Virtual Clinical Trials:

Another key trend that is slowly evolving in this context is complete virtualization of clinical trials. Pfizer is taking the lead in this space. While Pfizer’s REMOTE program is ongoing, an interim feedback from the program is provided by Mr. Craig Lipset, Head of Clinical Innovation at Pfizer is provided by Applied Clinical Trials in their article titled “Pfizer’s REMOTE Virtual Experience”. As highlighted in the article, they are going through the roadblocks of an early adopter.

Adoption of Enterprise Collaboration and Content Management:

Electronic communication and collaboration:

The above trends indicate that it is just a matter of time that total virtualization of clinical trials is accomplished. The key question that needs to be addressed is “How will the human interactions be virtualized?” The answer is “to adopt electronic communication and collaboration channels”. The channels can range from adopting systems to capture and manage clinical data, electronic source document verification to seamless communication and collaboration tools. The unique constraint with respect to clinical trials though is to ensure that the tools used adhere to “Good Clinical Practices” as well as other regulatory requirements like 21 CFR Part 11, HIPAA etc.

Enterprise Collaboration and Content Management Systems:

Systems for Electronic data capture (EDC), Clinical Data Management (CDM), Clinical Trial Management System (CTM), Adverse Event Management etc. are already available in the market. The key tool that would make it easier to seamlessly transition from human interactions to virtual interactions, in my view, is an Enterprise Collaboration and Content Management tool. Tools like Microsoft’s SharePoint, as highlighted in one of my previous blog posts, will help organizations make this transition fast and cost-effective. While it is always easier said than done, from real world experiences that we already have, it is relatively easy to adopt these tools in a GxP environment, meet all the regulatory compliance requirements and also accomplish the degree of flexibility required to easily communicate and collaborate.

Social Media and Mobility:

A couple more initiatives that could complement in the process are Social Media and Mobility. The need for a social media outreach program to increase the patient recruitment is highlighted by the channels Pfizer’s REMOTE program has adopted.  On similar lines, social media “like” features can be enabled on the collaboration and communication platform to be adopted. This can increase the accessibility and improve the response times from the patients. On similar lines, if the collaboration and communication platform can be made available over mobile devices like smart phones, tablets etc. the patient compliance and response times will improve considerably. Tools like Microsoft SharePoint make it easy to enable the social features and also deliver content to mobile devices.


Overall the ability of a sponsor or CRO organization increases tremendously to virtualize their clinical trial process by leveraging collaboration and content management tools. The overall “Risk-Based” approach to site monitoring and source document verification will also be “made easy” through these tools.  As noted in my previous posts, leveraging a tool like SharePoint for such purpose will improve the Return on Investment (ROI) and reduce the Total Cost of Ownership (TCO) of these tools.

As always, your feedback and comments are welcome.

Update, 20-Mar-2012:

This post has been picked up by and published on their website.

SharePoint in Life Sciences Value Chain

I was putting together a presentation for a session on “Enterprise Collaboration and Content Management” earlier this week. As part of the exercise I was making a list of point solutions, in each phase of the Life Sciences value chain, that can be developed using SharePoint. This sources for this list are various articles and publications, customer requests, actual applications that I have seen or delivered to customers and last but not the least, from my own brain. I thought of sharing the list here so it could be useful for some of you and might trigger your imagination on leveraging your SharePoint investments.

SharePoint in Life Sciences Value Chain

SharePoint in Life Sciences Value Chain

My intention is neither to say SharePoint will be a sophisticated solution for all the business needs mentioned above  nor that this list is exhaustive. I would like to argue that using SharePoint will definitely be an upgrade from age-old manual and/or paper based process which is still the norm in many organizations. For those who are skeptical about SharePoint being compliant with regulatory requirements like 21 CFR Part 11, I want you to know that it can be  “Validated”.  May be, that is a topic for another blog post in the future.

As always, your comments and feedback are welcome.

Safety Signal Management process automation using Microsoft SharePoint

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



Regulatory Document Management using SharePoint – 5 reasons to procure a COTS system

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.

Say NO to Installation Guides for LS COTS Applications

We have come a long way in the last three decades, in terms of computer programs, from Punched Cards to Instruction Sets for Assembly Language Programming (ALP) to Command Line Installations to point-and-click installations. All these methods of programming a computer to automate business processes required step-by-step instructions to install and run the programs for end users to leverage.

I still remember the days when I punched a bunch of Red, Yellow and Green LEDs into a PCB and hooked it up to my 8086 programming kit to simulate the traffic lights. I am glad my program, before I fixed it, was not used for traffic light control systems because it would have been a global disaster :-). Jokes apart, my point is that the instructions that come with software are equally important and will lead to better customer satisfaction, leave alone save the IT teams loads of frustration.

The reason I brought this up is, it is one thing to understand the instructions provided in the installation manuals but it is totally a different beast when you are tackling the Installation Qualification (IQ) requirements with in the Life Sciences space. This process requires every step of the process being recorded, QA Reviewed and signed off. This is all part of the larger Validation & Verification process that is mandated for all IT systems used in the industry (for regulated processes) to ensure regulatory compliance and for a good reason.

While the installation guides provide detailed instructions for the installation of the commercial off the shelf applications, the IT teams will have to go through the process of IQ documents for the same software again. This is not only a tedious process but also requires lot of review cycles to ensure right amount of detail and coverage. I think there is lot of duplication in terms of effort that the COTS vendors as well as the IT teams in life sciences organizations spend to document these steps. My argument is that the vendors of Life Sciences COTS systems should instead provide IQ document in place of the installation guide.

I understand the fact that each customer could have different formats for IQ and also different ways of capturing the steps. However, if a tool vendor provides the IQ document, instead of an installation guide, at least the customers that would be able to adapt the IQ ‘as-is’ will benefit. This will lead to reduction in amount of effort spent, lower costs and faster implementation cycles.

So, I would like to make an appeal to all the Life Sciences COTS vendors out there….”Think About IT“.

Feedback and comments are welcome.

%d bloggers like this: