A: With a new or significantly revised process, you should always be asking the question “How will we know whether it is working?” You need to establish measurements the evaluate the process. We applaud your approach! The Centralized & Site Monitoring Process Metrics Work Group has been discussing this exact topic. The work group developed a high-level process map that includes the centralized monitoring and remote/onsite site monitoring processes. The work group identified a series of questions about the process (aka Key Performance Questions) they wished to answer and are working on defining metrics to answer the questions. This approach ensures that our metric sets are comprised of metrics that provide actionable data.

The measurement that you state in your question is a type of time metric we call an “on time” or “timeliness” metric. The work group defined an alternative time metric that is a “cycle time” metric – instead of measuring if the task is completed within the timeframe you establish as the target, it measures the actual time it takes to complete the task.

The work group explored the pros/cons of each approach and concluded that the industry doesn’t have enough experience with the new process to determine what the target should be. Using a cycle time metric provides the opportunity for the industry to gather data on the new process and, in time, decide whether it is feasible and useful to have a timeliness metric that measures against a target. Additionally, upon review of the results, we may determine that critical risks should be assessed faster than others. Finally, we don’t want to encourage the premature closures of risks (prior to proper investigation) in order to meet timeliness targets without basis in understanding the process. Whenever metrics are defined and used, it is important to think critically about the purpose of the metrics and the behaviors they might drive.

Ask the Experts: Answers to your Metric Questions

With more organizations focusing on metrics, we have received an increase of questions ranging from how to use metrics, why some metrics are better than others, which type of metrics is best to use, as well as questions about specific metrics. This column provides a forum for us to share these questions and answers with you. Submit your question ›

Linda Sullivan

Senior Advisor, Metrics & Performance Management

WCG Avoca

Keith Dorricott

Metrics Subject Matter Expert

WCG Avoca

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The FDA and other Regulatory Agencies have established guidelines on enhancing the Diversity of Clinical Trial Populations for the Industry. Despite promoting enrollment practices that would lead to clinical trials that better reflect the population most likely to use the drug (if approved), challenges to diversified participation in clinical trials remain and certain groups continue to be underrepresented in many clinical trials. Adopting more-inclusive enrollment practices should improve the quality of studies by ensuring that the study population is representative of the patient population likely to use the drug in clinical practice.

In alignment with FDA and other Regulatory Agency recommendations for promoting diversity of clinical trial populations, WCG Avoca has developed a Site Diversity Workbook which provides:

• Support for inclusion of racial and ethnic minorities in clinical trials based on disease burden and the ability to analyze clinical trial data by race and ethnicity.

• A tool for Sponsors and Investigators to assess the success of their diversified recruitment efforts and to identify areas of opportunity.

• Assistance for Sponsors and Investigators in drawing insight needed to optimize organizational spending, improve diversity recruitment efforts, help reach patient diversification goals, and evaluate the impact on their clinical trials.

AQC Members can access the Site Diversity Workbook in the Knowledge Center here.

This is just one of many risk-based tools available to WCG Avoca Quality Consortium Members in our Knowledge Center, which consists of over 500 regulatory compliant leading practice tools and templates customizable to their organization to be inspection ready. View the current catalog of tools.

Interested in joining the AQC? Contact us and join our next monthly Knowledge Center demo.

The post Achieve More Diverse Trials with the AQC Site Diversity Workbook appeared first on Avoca, a WCG company.

The FDA has established Risk-Based Monitoring guidance* which encourages sponsors to tailor monitoring plans to the needs of the investigation, describes factors to consider in developing a monitoring plan, and provides examples of monitoring methods and techniques. The FDA believes risk-based monitoring is an important tool to allow sponsors to identify and address issues during the conduct of clinical investigations.

In alignment with FDA’s recommendations on Risk-Based Monitoring, WCG Avoca has developed a Risk-Based Monitoring Plan Template which provides:

• Instruction for Sponsor/CRO oversight activities which focus on critical data and processes with the intention of mitigating those that will impact data quality, human subject protection, and reliability of trial results.

• Support and corresponding resources for identifying risks in a Quality Risk Management Plan (IQRMP) and setting Quality Tolerance Limits (QTLs) and Key Risk Indicator thresholds, so that resources can focus on monitoring activities that provide the most value.

• Assistance for ensuring that the rights, confidentiality, and safety of human subjects are protected; that trial data are accurate, complete, and verifiable; and that the study is compliant with the protocol, Good Clinical Practice (ICH/GCP), and all applicable regulatory requirements.

• An efficient monitoring strategy that best aligns with any heightened or critical risks of a particular trial with the intent to prevent the realization of those risks; to ensure early detection of impactful issues; to control those risks to an acceptable level; and to correct all significant and critically impactful issues while the trial is ongoing.

• Adequate information for those involved in monitoring to effectively carry out their monitoring duties, taking into account the objectives of monitoring when applying a risk-based strategy.

AQC Members can access the Risk-Based Monitoring Plan Template in the Knowledge Center here.

This is just one of many risk-based tools available to WCG Avoca Quality Consortium Members in our Knowledge Center, which consists of over 500 regulatory compliant leading practice tools and templates customizable to their organization to be inspection ready. View the current catalog of tools.

Interested in joining the AQC? Contact us and join our next monthly Knowledge Center demo.

*References:

• A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers – March 2019 Guidance Document
• Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring – August 2013 Guidance Document

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TMF Regulatory Requirements

Because of The Avoca Group’s extensive experience consulting for inspections/audits and the Avoca Quality Consortium® (AQC) Member companies’ input regarding their experiences with inspections/audits, The Avoca Group is able to provide unprecedented insight into the expectations of regulatory agencies. Based on these experiences and case studies, we’ve determined that inspectors often check that the TMF is complete, can be accessed directly, has audit trails to ensure record/data integrity, and contains original/certified copies of the documents.

Before addressing some of the questions for each of these inspection points that were asked during the webinar, it’s worthwhile revisiting some of the key principles from regulatory agencies.

EMA’s Good Clinical Practice Inspectors Working Group (GCP IWG) DRAFT Guideline on GCP compliance states “A TMF is the collection of essential documents that facilitates the conduct and management of the clinical trial and allows that the integrity of the trial data and the compliance of the trial with GCP can be evaluated.” According to Article 57 of the regulation, the essential documents are “those pertaining to the trial which allow verification of the conduct of the trial and the quality of the data generated.” Therefore, documents that are generated from following the systems and procedures that assure the quality of every aspect of the trial are considered essential documents.¹

The FDA’s Draft Guidance to Industry Data Integrity Compliance with cGMP states that “data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).”²

According to the WHO’s Guidance on Good Data and Record Management Practices, “The audit trail is a form of metadata that contains information associated with actions that relate to the creation, modification or deletion of GXP records … creation, additions, deletions or alterations of information in a record, either paper or electronic, without obscuring or overwriting the original record. An audit trail facilitates the reconstruction of the history of such events relating to the record regardless of its medium, including the “who, what, when and why” of the action.”³

Therefore, the inspections around the TMF stem from the need to ensure that good practice is being followed to ensure the integrity of the data from which decisions regarding new drugs/devices are being made.

Completeness – Hybrid TMFs

According to the regulatory agencies, the TMF needs to provide all essential documents relevant to the clinical trial.

When the eTMF is a hybrid model (paper/electronic), the MHRA and EMA specifically have a strong preference to directly access eTMFs for inspection purposes. If a sponsor TMF is paper and the CRO TMF is electronic, then the sponsor is accountable for the entirety of all documents that support the conduct of the clinical trial, patient safety, and data integrity. The sponsor’s quality management system (QMS) should clearly articulate how the paper-based TMF and eTMF operate together to complete the TMF. Additionally, the contract or other document or procedure agreed between all parties should outline the arrangements for the TMF (which should include how the TMF would be made available if either party were to be inspected).

The TMF should include emails that contain relevant and important information about the clinical trial conduct; decisions that affect patient safety, data integrity, or key risks for the trial; and any documentation of actions taken for these items. However, having said this, best practice is not to document these items within emails, but rather to document them in actual team or study documents such as meeting minutes, trip reports, monitoring reports, or analysis reports.

One attendee reported experience with two MHRA inspections with different companies, during which the MHRA had a focus on data flows, data integrity, and awareness of the MHRA data integrity guidance. In our experience, although data flows are highly recommended, they vary widely among sponsors, studies, etc. It is important that the diagram include all data from the source (including sites, external vendors) to the generation of the tables/listings and any other format that goes into the CSR.

Accessibility

The MHRA and EMA expect that the eTMF will be straightforward in terms of use – not requiring extensive training for the inspector. They request direct access to it with minimal orientation.

Regarding access to data records, guided access is acceptable for certain data records within an esystem in addition to direct access to the TMF system. For example, we were asked during the webinar specifically about safety data – it is acceptable to reference in your TMF index the location of source safety data and direct an inspector to the Safety Database as the central repository for safety data. Other examples include audit trails and eCRF and CTMS. This is due to the technical nature of some of these systems, which might contain data rather than documents.

Audit Trails for Record/Data Integrity

How inspectors want to view the TMF’s audit trail differs by regulatory agency – whether it be the system’s back-end or an export of the audit trail. Certainly, the MHRA is known to request access to the TMF metadata, including the audit trail. If/where there is a particular reason why access to system back-end is not available, provision of exported audit trail can be negotiated, provided it is reliable (i.e., from a validated system).

The Avoca Group has many industry-leading oversight tools, and audits have been performed of these tools in practice, which have been found acceptable. A case study was presented by Alexion during the 2015 Avoca Quality Consortium Fall Members’ meeting regarding an agency inspection of their pharmacovigilance QMS. They had used Avoca leading practices. Upon completion of the inspection, the inspector indicated that it was the most effective management system he had seen. This case study is available to all AQC Members in the AQC online Knowledge Center. Other examples are available upon request.

Original/Certified Copies of Documents

Finally, we received multiple questions about document certification. Per EMA/15975/2016 definition (aligned with ICH), a certified copy is a paper or electronic copy of the original record that has been manually verified (e.g., by a dated signature) or has been generated through a validated process to produce a copy with the exact content and meaning of the original.

The best practice for certifying a document in an eTMF is to have a well-defined process in place that includes qualified individuals who are assigned to generate a copy, verifying (certifying) that it is identical to the original and signing for accuracy or have a procedure that documents the validated electronic process for generating the copy. There must also be internal organizational audit verification that copies are consistent with originals.

Regarding which TMF content requires a certified copy, the general principle is that original documents that are required for the TMF (e.g., ICH essential documents and/or other documents that are pertinent to the study) need to be transferred to an electronic format for eTMF filing. The transfer process should be validated and undergo regular quality control checks to ensure that the information will not be lost or altered. Whether the original hard-copy documents are kept by the CRO once they are uploaded into the eTMF depends on the risk level acceptable to the CRO and sponsor. In concept, once a document has been certified via a validated and documented approach, paper copies may be destroyed. Section 5.2 “Destruction of original paper after digitization” of the Draft EMA Guideline outlines several relevant points for consideration when making this risk-based decision.²

In the common scenario where the site process is to retain original (wet ink-signed) essential docs and they do not have a process to send in certified copies for filing in the eTMF, sites either send copies to the monitoring organization, post a scanned copy of the original in the eTMF, or have them collected by site monitors for filing in the TMF/eTMF. Since the site will have the original documents in the Investigator Site File that are verified by the site monitor, it is not typically expected that a certified copy process is implemented [since the original record remains available in the ISF (TMF)].

View and download the Webinar on which this blog is based. >>

Because this post was guided by the questions asked during our webinar, it touches only on a segment of all the considerations for the TMF. For additional information about any of these topics, the guidance documents issued by the regulatory agencies^1-4 provide their expectations for the majority of scenarios. Of course, we at The Avoca Group are available to provide our perspectives based on our experience and those of the AQC Member companies. For more information about our Consulting services, click here.

1. EMA: EMA/15975/2016, Good Clinical Practice Inspectors Working Group (GCP IWG), DRAFT Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials, March 31, 2017: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/04/WC500225871.pdf
2. FDA: DRAFT Guidance for Industry Data Integrity Compliance with cGMP, April 2016: https://www.fda.gov/downloads/drugs/guidances/ucm495891.pdf
3. WHO: Guidance on Good data and Record Management Practices, Annex 5, September 2015: http://apps.who.int/medicinedocs/documents/s22402en/s22402en.pdf
4. MHRA: GxP Data Integrity Guide, March 2018: https://www.gov.uk/government/publications/guidance-on-gxp-data-integrity

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Although the FDA released risk-based monitoring guidance in 2013, it wasn’t until the release of ICH E6 (R2) in 2016 and its focus on risk-based monitoring that the industry began to shift from 100% SDV to risk-based approaches.

Because of R2’s focus on risk and the need to comply with these guidelines, the majority of conversations held at the Quality Congress centered around risk-based methodologies. These discussions highlighted frustrations felt from all sides of the clinical trial landscape.

The two most commonly voiced frustrations were unclear communication and lack of transparency. Unclear communication, we heard, was not the result of bad intentions. Instead, it became quickly apparent that the industry as a whole does not have a clear understanding or definition of risk-based monitoring.

Key monitoring-related terms often include risk-based monitoring, central monitoring, site monitoring, on-site monitoring, and remote (or off-site) monitoring. Each of these types of monitoring comes with different roles and responsibilities. For efficient, effective monitoring, we need to ensure that all players in the monitoring of the clinical trial understand what is expected from both the monitoring and their role (Figure 1).

Click image to enlarge

Figure 1. David Vulcano, HCA Healthcare and Leadership Council for Society for Clinical Research Sites, and Jennifer Hebert, PAREXEL, created this diagram to define and outline the relationship between the types of monitoring.

The issue around lack of transparency was related to expectations for risk-based monitoring plans. Sites noted that the first step in reducing frustration and increasing site efficiency is understanding what is expected at monitoring visits, while sponsors noted that, to avoid a focus solely on the datapoints and main areas in the risk-based monitoring plans, they do not frequently share the plans with sites.

However, the shift toward risk-based monitoring has also moved the responsibility for quality control check from CRAs to the sites themselves. When CRAs were responsible for the quality control check with 100% SDV, the sites could be assured that the data they entered was of high quality because of the second set of eyes reviewing it.

With risk-based monitoring approaches, the ability to review the study monitoring plans would allow sites to focus their quality control efforts on the datapoints and/or focus areas that will not be checked again by the Sponsor. This issue was an example of a clear misunderstanding that, when discussed openly, seemed to have a very rational outcome: risk-based monitoring plans would be shared with sites so they can implement quality control steps where most appropriate.

Conversations like these increase industry-wide quality and efficiency in clinical trial execution. It is our hope that conversations of this nature will be ongoing as The Avoca Group continues to involve sites in the development of quality tools within the Avoca Quality Consortium®.

The post Sites Offer Key Insights to Challenges of Risk-based Methodologies Associated with ICH E6 (R2) appeared first on Avoca, a WCG company.

Passive vs. Active

The Avoca Group’s research, documented in the 2017 Avoca Industry Report, shines a light on what’s happening with risk assessment and management across the board. First, the type of refinements sponsors and providers are willing to make tend to be more passive than active in nature.

Changes to the review plan for performance data or to the monitoring strategy are the most prevalent actions taken in response to risk assessments. In contrast, more aggressive actions, such as changes to trial operations – including changing the number or disposition of specific sites – are far less common.

Basically, sponsors and providers are willing to make “safe bets” – things that don’t have a huge impact on clinical trial operations or results. For example, a sponsor might increase the frequency of monitoring or the number of training sessions required. Such actions may or may not benefit the clinical trial, but they certainly won’t hurt it in any way.

However, when it comes to matters such as potentially changing the number of sites involved in a clinical trial – a decision that could seriously impact the logistics, cost, and outcomes of a trial – the willingness to take the plunge decreases substantially.

Severity vs. Detectability

A second point of consideration involves the components of risk assessment. ICH E6 (R2) lays out three areas of risk assessment: severity, probability, and detectability. Sponsors and providers are doing a good job assessing the severity or level of harm that a risk carries. Assessing the probability of a risk event lags behind that a bit but is still respectable. Nonetheless, the numbers definitely take a dive when looking at how often detectability is being assessed.

This brings up an important point: if sponsors and providers cannot see a looming risk, how can they address it? If sponsors and providers cannot detect where a risk lies, they are completely exposed to that risk.

Qualitative vs. Quantitative

Third, it should be noted that one of the goals of risk-based assessments is to give sponsors and providers hard facts to consider in decision-making processes. But, while approximately half of each group are using a hybrid approach of both qualitative and quantitative methods to assess risk, a significant minority still use a primarily qualitative approach to risk assessment.

This shows that there is work to be done for sponsors and providers overall to move to the place where they can say, “This is the data we used in our risk assessment. This is how we analyzed it. This is how we applied our expert judgment to that analysis in making our decision.” That mix of qualitative and quantitative approaches is where the highest level of benefit will be realized.

What’s the Impact?

One of the biggest red flags raised by the 2017 Avoca Industry Report is that both sponsors and providers view the new risk assessment and management approaches as having only a moderate impact on increasing quality.

Considering that the whole focus of ICH E6 (R2) is to improve quality in clinical trials, this is not good. It would be easy to blame the lack of impact on the nature of the ICH E6 (R2) guidelines. But the previous points beg the question: Might this lack of impact be attributable to…

• A tendency to prefer passive refinements to active ones.
• An uncertainty about how to assess detectability, as compared to severity, of risks.
• The exclusive use of qualitative methods for assessing risk, rather than a hybrid qualitative/quantitative approach.

In other words, are we not seeing a bigger impact because we have not been willing to make bigger bets? As long as sponsors and providers “play it safe,” it is reasonable to anticipate only mediocre results. What impact would ICH E6 (R2) have if sponsors and providers made aggressive refinements to their clinical trials based on their risk assessments? What would happen if risks could be detected with a high degree of precision? What if assessments were based on the perfect blend of the subjective and the objective?

I suspect that the impact which would result would, once and for all, answer in the affirmative the ultimate question: “Is this sustainable?”

Is your company moving toward greater use of risk-based approaches for quality and oversight? The Avoca Group specializes in supporting sponsors and CROs to comply with ICH E6 (R2) through the use of risk-based approaches to quality and oversight. The Avoca Group’s consulting services are grounded in the leading practices and tools from the Avoca Quality Consortium® and customized to drive measurable improvements to quality and execution of clinical trials. To learn more, or to speak with a representative, contact us.

Download Avoca’s 2017 Industry Survey Report

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Author:

Dennis Salotti Vice President, Operations, The Avoca Group

The post Are Risk-based Approaches to Assessing and Managing Clinical Trials Sustainable? appeared first on Avoca, a WCG company.

To begin, it is important to establish how familiar sponsors and providers are with risk-based approaches to quality management. Avoca’s research reveals that nearly 70% of sponsor respondents indicate having a “good” or “very good” understanding of best practices in risk-based quality management. While this is encouraging, it is significantly lower than the nearly 90% of providers who indicate this level of knowledge.

Breaking this down further, among providers, understanding of risk-based quality management was consistent by function across Quality and Clinical Operations. However, among sponsors, those in Clinical Operations expressed a substantially lower level of familiarity than did those representing the Quality function.

We can view this gap as an opportunity for Quality and Clinical Operations to increase collaboration and knowledge sharing. It may also indicate the need for a mindset shift in sponsor organizations from viewing quality management as “Quality’s job” to seeing it as “everyone’s responsibility.”

Familiarity with risk-based quality management protocols will also undoubtedly improve as the frequency of use increases. Currently, approximately 50% – 60% of sponsors and providers reported that risk-based quality management is being utilized in at least half of the trials they run. That is a positive sign but leaves significant room for growth.

Utilization is one thing – results are another. The Avoca report notes that approximately half of respondents indicate that risk-based quality management has been “very” or “extremely” impactful on increasing quality in trials; far fewer, however, feel this is resulting in improvements to efficiency in terms of time or resources.

When we put all these statistics together, what do we see with regard to risk-based quality management?

• Familiarity is good overall … but it could improve.
• Utilization is reasonably good … but it could improve.
• Impact is trending in a good direction … but it could improve.

This assessment might leave you feeling ambivalent about the long-term effectiveness and sustainability of risk-based quality management. But numbers aren’t the only considerations. The 2017 Avoca Industry Report also gathered verbatim commentary from respondents on the use of risk-based quality management. That commentary suggests that the use of risk-based quality management can positively influence awareness, communication, and strategy within and between sponsor and provider organizations. For example, respondents noted:

• “Planning has opened communication amongst team.”
• “Increased awareness of threats to quality of study.”
• “Our teams are constantly meeting and reassessing to make sure that the potential risks and actual risks are being pointed out and dealt with.”

Certainly, challenges were also reported, such as gaining alignment on rationale, process, and measurement. But even these challenges have their positive aspect if they drive greater collaboration between Quality and Clinical Operations, and among sponsors and providers.

Taken all in all, if risk-based quality management is bringing people together in new ways, that can only be viewed as valuable to the future of clinical trials and to the patients who are ultimately being served.

Are you concerned about compliance and effectiveness of your QMS or risk-based oversight practices? Avoca can help. We specialize in installing or remodeling Quality Management Frameworks that comply with ICH E6 (R2) and utilize risk-based approaches to quality and oversight. Avoca’s consulting services are grounded in the leading practices and tools from the Avoca Quality Consortium® and customized to drive measurable improvements to quality and execution of clinical trials. To receive information or to speak with a representative, contact us.

Download The 2017 Avoca Industry Report: Using Risk-Based Approaches to Quality Management

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Author:

Dennis Salotti Vice President, Operations, The Avoca Group

The post Risk-Based Quality Management: Working It Out in the Trenches appeared first on Avoca, a WCG company.

The striking change is the spirit in which the new set of guidelines is encouraging a shift in mind set in managing quality in clinical trials. ICH E6 (R2) is calling upon legions of drug development professionals to recognize that all risks are not of equal importance from a compliance and quality perspective and the key to effectively achieving quality is through making key decisions based on a careful assessment of risk.

Risk, a term that usually tends to invoke shudders because it is all about the “possibility that something can go wrong” is now omnipresent in quality management.  Risk based approaches to oversight, monitoring, inspections and more are the new normal.

There is a lot of frenzy around understanding the guidelines.  There are a lot of processes being put in place to make sure that ICH E6 (R2) is kept at the forefront of the way clinical trial processes evolve.  My question is this.  How are organizations getting their teams to change their mindset?  As far as I can remember, the words quality and compliance were at the heart of decisions.  How does one get employees to talk about and manage risk?

Since the launch of our Avoca Quality Consortium (AQC) five years ago, we have been working with our Members to prepare for this changing environment through the raising of awareness, cross-industry dialogue and the development of proactive, tool based approaches to managing quality.  Our Members believe that the best way to approach this change is to get the conversations flowing, not just within companies, but across the clinical trial ecosystem.

At our recent AQC Member meeting with executives, we heard loud and clear that the industry is mobilizing resources to understand and respond to the new guidelines.  This is now on top of our initiatives for 2017 where we will help our Member companies to understand the implications of ICH E6 (R2), guide them with leading practices and develop tools to respond and stay ahead.

We’d love to hear your thoughts on where you are in your journey in this risk based world of quality management.

Until next time………

Lakshmi

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Lakshmi Sundar has spent two decades in the pharmaceutical industry, leading teams across sponsors and CROs in multiple functional areas to spark innovation, manage risk, and lead change with a sense of purpose and fun. At Avoca, Lakshmi partners with members of the Avoca Quality Consortium and industry innovators to deepen the dialogue on building a quality culture within and across organizations to mitigate risk, advance drug development, and bring treatments to patients in a more effective manner. 

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This is a query that is routinely being asked by risk management professionals across industries.  How does an organization mitigate risk?  Risk, the dreaded possibility that something bad or unpleasant will happen.  The challenge we face in drug development is that, in many instances, we appear to be managing issues rather than risks.  Why is this so prevalent?  For one, it is sometimes easier to address a problem when it drops in front of us rather than trying to figure out the possibility that a problem will occur, the impact it could have, the resources it might take to address, and more.  Risk mitigation planning is a thoughtful, time-consuming process that requires resources.  And, as we heard earlier this year at our Avoca Quality Consortium (AQC) Summits, time/resources are a scathing challenge for drug development professionals.

The good news?  Drug development professionals know that firefighting is not a sustainable way to operate in a journey that continues to get more challenging and expensive with each passing day.  I saw this recognition and enthusiasm for change firsthand in the over 200 attendees that listened and engaged in a recent webinar entitled, “Utilizing Proactive Risk Management Mapping as an Effective Clinical Oversight Process and Tool.”  These attendees wanted to know more, asked about tools, enquired about processes, all in the interest of embracing a thoughtful way to manage risk rather than continue with the daily firefighting.

Here are some of the top-of-mind questions I heard from attendees:  Risk Mapping Webinar Q&A

If you are curious to hear the discussion in detail, you can access a recording of this webinar here:  Risk Mapping Webinar

Oh, and right as I completed this post, I happened to talk to two AQC members who are leading a seamless multidisciplinary partnership across GxPs to mitigate risk proactively and have success stories to tell.  Very encouraging indeed!

Where is your organization in this journey?  Do you believe that firefighting as a culture needs to change?  What’s standing in the way of this change?  I’d love to hear your thoughts/debates.

Until next time………

Lakshmi

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Lakshmi Sundar has spent two decades in the pharmaceutical industry, leading teams across sponsors and CROs in multiple functional areas to spark innovation, manage risk, and lead change with a sense of purpose and fun. At Avoca, Lakshmi partners with members of the Avoca Quality Consortium and industry innovators to deepen the dialogue on building a quality culture within and across organizations to mitigate risk, advance drug development, and bring treatments to patients in a more effective manner. 

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