Keeping Clinical Investigators Happy, Productive, and Loyal
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A recent joint study conducted by the FDA and Duke University found that 54% of clinical investigators only complete a single study. This alarmingly high turnover rate means that pharmaceutical, medical device, and contract research organizations (CROs) need to drastically improve their relationships with investigators and sites – now. In this SlidShare, Param Singh, director of clinical operations solutions, presents a practical approach to solving this common, yet serious, business problem. He will discuss specific scenarios and demonstrate how to address them.
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Keeping Clinical Investigators Happy, Productive, and Loyal
- 1. Keeping Clinical Investigators Happy, Productive, and Loyal July 13, 2017
- 2. 2 About Perficient Perficient is the leading digital transformation consulting firm serving Global 2000 and enterprise customers throughout North America. With unparalleled information technology, management consulting, and creative capabilities, Perficient and its Perficient Digital agency deliver vision, execution, and value with outstanding digital experience, business optimization, and industry solutions.
- 3. 3 Perficient Profile Founded in 1997 Public, NASDAQ: PRFT 2016 revenue $487 million Major market locations: Allentown, Atlanta, Ann Arbor, Boston, Charlotte, Chicago, Cincinnati, Columbus, Dallas, Denver, Detroit, Fairfax, Houston, Indianapolis, Lafayette, Milwaukee, Minneapolis, New York City, Northern California, Oxford (UK), Southern California, St. Louis, Toronto Global delivery centers in China and India ~3,000 colleagues Dedicated solution practices ~95% repeat business rate Alliance partnerships with major technology vendors Multiple vendor/industry technology and growth awards
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- 5. 5 Today’s Presenter Param Singh • Director, Life Sciences • Leads clinical operations and connected health initiatives • 9 years with Perficient • 15 years in life sciences 5
- 6. 6 • Why prioritize the investigator relationship? • Countdown of 7 relationship strains, along with examples of effective solutions • Where to go from here • Links to additional resources Agenda
- 7. 54.2% of investigators complete just one study Source: One and done: Reasons principal investigators conduct only one FDA-regulated drug trial. Contemporary Clinical Trial Communications, Volume 6, June 2017, Pages 31-38.
- 8. 8 #7 Cumbersome Site-monitoring Visits ISSUES • Site monitoring is both important and burdensome • Monitors struggle with: • Scheduling visits • Accessing what they need during visits • Completing reports and routing them for review and approval • Ensuring sites address outstanding issues • Sites struggle with TIME: prep, hosting, and addressing issues GUIDANCE • Adopt a risk-based monitoring (RBM) approach • Automate prep and follow-up notifications • Provide monitors with convenient tools that facilitate the process • Streamline report creation, review, and approval • Automatically share relevant parts of approved reports with site personnel
- 9. 9 #7 Cumbersome Site-monitoring VisitsSiteMonitor SiteStaff Member Schedules the visit with the site (online or via the mobile app) End Start Receives a notification that one of her sites is due for a monitoring visit You Review and approve the monitoring report Conducts the visit and completes the visit report using the interactive mobile app Submits the report for review and approval Receives automatic reminders and preparation tips Hosts the site monitor Receives a notification that the monitoring visit results have been published
- 10. 10 #6 Ineffective Subject Screening ISSUES Too many screen failures + Too many early terminations = Too much time and expense lost GUIDANCE • Provide site personnel with tools that boost their screening effectiveness, and continually monitoring and improving those tools over time • Shift the burden of the screening process away from site personnel • Automate the data capture process during the screening visit
- 11. 11 #6 Ineffective Subject Screening (Solution 1)Potential Subject SiteStaff Member Follows the interactive prompts in the screening mobile app on her iPad End Start Comes into site for his screening visit You After noticing several issues with a particular screening criterion, you initiate a protocol amendment workflow Once the amendment has been approved, you make the update to the mobile app Watching over time, you see improvement in the updated screening criterion and overall recruitment Gets tripped up on a specific screening criterion, but makes it through Automatically receives the updated version of the mobile app
- 12. 12 #6 Ineffective Subject Screening (Solution 2)Potential Subject SiteStaff Member Explains the self- screening process: going from station to station and interacting with each digital device EndStart Comes into site for his screening visit Thanks the potential subject and informs him of next steps Interacts with each digital device to complete his self-screening tests Investigator Receives a notification that a potential subject tentatively passed screening Reviews screening results and approves subject for enrollment Receives a welcome notification with a request to complete informed consent
- 13. 13 #5 Clinical Data-entry Mistakes ISSUES Dirty clinical data: • Slows time to market • Increases development costs • Stalls (or stops!) new drug applications (NDAs) • Damages relationship with site GUIDANCE • Leverage digital technology and the Internet of Things (IoT) in clinical data collection!
- 14. 14 #5 Clinical Data-entry Mistakes (Solution 1)ClinicalSubject SiteStaff Member Issues the clinical subject his wrist tracker and digital skin patch End Start Receives automatically transmitted results Downloads the medication adherence mobile app on his mobile phone Wears his wearables as agreed upon during informed consent Receives push notifications via the mobile app to take his medication Receives automatically transmitted results Receives a notification that the subject s blood pressure is running high Receives a notification that an appointment is needed Schedules his appointment via the mobile app and receives reminders
- 15. 15 #5 Clinical Data-entry Mistakes (Solution 2)Potential Subject SiteStaff Member Receives notifications when entries are submitted End Start Downloads the patient diary mobile app onto his phone You Receive a notification of a potential adverse event Kick off your safety signal evaluation process Receives a notification of a potential adverse event in one of the entries Receives push reminders to log his diary entries Uses the interactive mobile app to log his entries on schedule Receives environmental data from the other apps on his phone
- 16. 16 #4 Slow Subject Recruitment ISSUES • Even promising sites can struggle with subject recruitment • Pressure from CRO upper management or the sponsor to meet recruitment targets stress and anxiety for study managers strains relationships with underperforming sites GUIDANCE • Broaden the site’s pool of potential subjects • Build a database of potential subjects • Leverage the social networks of potential subjects for recruiting purposes
- 17. 17 #4 Slow Subject RecruitmentPotential Subject SiteStaff Member Receives a profile for someone nearby who meets the minimum eligibility criteria for a current study Receives an invitation to schedule a screening visit at a nearby site After failing the screening visit, receives an automated request to help recruit others via his social network EndStart Receives invitation to apply to participate in a study (website popup, Google ad, etc.) Creates a login, fills out a profile, and submits
- 18. 18 #3 Problems with Payments ISSUES • Significant drain on sponsor/CRO resources • Complex, manual investigation processes • Slow turnaround time • Lack of transparency with sites • Leads to site personnel feeling frustrated, undervalued, and distrustful • Further leads to decline in site productivity GUIDANCE • Provide sites with a comprehensive history of payments that have been issued to them • Equip sites with self-service tools to open claims against payments that seem incorrect • Give sites the ability to see the status of open claims over time • Automate claim investigations and resolutions, where possible and appropriate
- 19. 19 #3 Problems with PaymentsInvestigatorYou Start Views the complete log of payments she has received to-date Notices a payment that seems incorrect and drills down into the details Perform your investigation and update the claim status Opens a claim against the payment Watches the claim status over time End Receives a notification that explains the claim resolution Receive notice of a claim that was not resolvable through automated workflows Resolve the claim and update the claim status
- 20. 20 #2 Outdated Contact Details ISSUES Outdated site contact details can result in: • Delayed or lost site essential documents • Difficulty scheduling monitoring visits • Difficulty communicating about monitoring visit action items • Delayed or lost clinical supplies shipments • Delayed or lost site payments GUIDANCE • Empower sites to see the contact information on file for them at all times • Provide sites with self-service tools to update their contact information • Periodically prompt site personnel to verify their contact information on file
- 21. 21 #2 Outdated Contact DetailsSiteStaff Member You Start Receives a prompt to verify that her contact information is correct Reviews her information and notices outdated information Receive a notification of a newly submitted update Review the content of the update Accept the update Updates the information and submits the update Watches the status of the update over time End Receives a notification that her update was completed
- 22. 22 #1 Poor Clinical Document Compliance ISSUES • Ongoing battle for every sponsor and CRO • Volume of required documentation is daunting • Rather burdensome for sites • Can lead to audit findings against sponsors GUIDANCE • Provide sites with greater visibility into their document compliance status • Automate notifications related to upcoming and past-due document deadlines • Enable easier document reviews, approvals, and sharing back and forth
- 23. 23 #1 Poor Clinical Document ComplianceSiteStaff Member You Start Receives a notification that a document on file expires in 30 days Receives a notification that the document now expires in 14 days Receive a notification that the expiring document has been updated Updates the document Logs in, finds the document currently on file, and uploads the updated version End Sees that the site s overall document compliance is back in good standing Receive a notification about an expiring site document
- 24. 24 Where to Go from Here Confident some or all of these issues apply to your organization? Let us show you the solutions in action. Not sure about the root of the issues you have with your sites? Partner with us to uncover the answers.
- 25. 25 • A Proven Methodology for Improving Clinical Site Performance | Download • Incorporating Digital Technology into Clinical Trials | View On Demand • Modernizing Clinical Trial Operations with Digital Experience Technologies | Download • Cultivating Patient-Pharma Relationships in the Digital Era | View On Demand • Life Sciences is Going Digital: 30 Examples from Industry Leaders | Download Additional Resources • Perficient.com/SocialMedia • Facebook.com/Perficient • Twitter.com/Perficient_LS • Blogs.perficient.com/LifeSciences
Notes de l'éditeur
- Eugene
- Eugene
- Eugene
- Eugene turns it over to Param
- Why prioritize the investigator relationship Countdown of 7 relationship strains, along with examples of effective solutions (presented in order of least pressing to most pressing, as voted by YOU) Where to go from here Links to additional resources No time for Q&A today (30-minute format) (But I will be available via email after the webinar to answer questions) We’ve got a lot to cover, so let’s get started!
- I wanted to kick off today’s webinar with this quote from a study that came out earlier this year because it really encapsulates the urgency of the topic at hand – the relationship between sponsors or CROs and clinical investigators. When more than half of your PIs are walking away after you’ve gone through the trouble of getting their site up and running, you’ve got a really expensive problem that needs to be solved ASAP. Well, I’ll tell you: In our nearly 20 years of working with the life sciences industry, we’ve spoken with countless pharmaceutical companies, medical device companies, and CROs about their relationships with clinical sites and investigators – many of whom are actually on today’s call. We’ve listened to their struggles and the things they’ve tried to make things better, including what’s worked and what hasn’t. We’ve learned a lot from these organizations and, by helping them understand their sites as customers, we have been able to successfully advise and support them in designing and implementing effective solutions. Today, we’re going to share with you our insight into this unique relationship. In today’s webinar, we’re going to highlight the seven most common issues that strain the relationship between sponsor/CRO and site/investigator, and provide guidance on proven, practical solutions for each one. We’ll go through them in countdown style, from smallest issue to biggest issue, as voted by all of YOU!
- While sponsors, CROs, and clinical sites all acknowledge that site monitoring is a necessary part of ensuring clinical trials are run in compliance with governing regulations and protocols, it can be a rather burdensome process, both for monitors and for sites. Monitors struggle with scheduling the visits, having access to everything they need during the visits, completing their reports, getting those reports reviewed and approved, and ensuring sites address any outstanding issues they identify. Sites struggle with taking the time to prepare for and host the visits, as well as to address the follow-up issues, on top of the burden of running the trial and handling their regular patient load. These struggles – on both sides – can be reduced by: Adopting a risk-based monitoring (RBM) approach, so that sites are only monitored when necessary Automating preparation and follow-up notifications Providing monitors with convenient tools that facilitate the monitoring process Streamlining report creation, review, and approval Automatically sharing relevant parts of approved reports with site personnel
- One of the more thoughtful solutions we have seen to this issue works like this: Based on predefined clinical data and milestones, a site monitor receives a notification that one of her sites requires a site monitoring visit. She works with the site to schedule the visit, and both she and the site receive automated confirmation emails. The day of the visit, the monitor arrives at the site with her iPad, which contains a proprietary site monitoring mobile app. She finds that the site’s wireless internet is down for the day, so she uses the app in offline mode. Throughout the visit, she uses the interactive, decision-tree-based user interface to address all of the topics, ask all of the questions, and record all of the answers. She even uses the iPad camera to take photos and attach them to the report. After the visit, when she gets back online, the app syncs with the system and she is able to issue the report for review. After receiving her manager’s feedback and making the adjustments, she routes the report for approval. The app allows her and her manager to apply 21 CFR Part 11-compliant digital signatures, and also maintains a complete audit trail of the report’s review and approval history. Once approved, the details from the report that are relevant to the site are automatically shared with the site in a read-only capacity, and follow-up emails that include action items and due dates are automatically sent to all parties. Combining risk-based monitoring with convenient and effective digital tools can significantly improve the site monitoring experience, both for monitors and for site personnel. The ideal approach minimizes the burden on all parties without compromising the quality of the monitoring process, which this solution accomplishes beautifully. And the collaborative and transparent nature of the process inherently boosts the monitor-site relationship.
- Even when sites are able to recruit a large pool of potential subjects, sponsors and CROs see far too many subjects who fail to pass the screening visit (screen failures) and subjects who pass the screening visit only to leave the study early (early terminations). Because sites get paid for every subject visit that occurs, regardless of whether the subject passes or completes the study, both of these situations are costly and lead to tension between the sponsor/CRO and the site/investigator. This strain can be eased by: Providing site personnel with tools that boost their screening effectiveness, and continually monitoring and improving those tools over time Shifting the burden of the screening process away from site personnel Automating the data capture process during the screening visit
- We have seen companies tackle this issue effectively in two primary ways, both of which leverage digital technology and CX principles. Imagine the following: A potential clinical subject comes into a site for his screening visit. The nurse performing the screening visit takes out her iPad, brings up the screening app, and follows the interactive prompts to move the potential subject through the various questions and tests. When the nurse selects or inputs the potential subject’s answers, the app dynamically adjusts the questions that are asked, and their sequence, in a decision-tree format that is relevant to the potential subject. When the nurse performs the tests, the data is automatically captured in the app via wireless connection with the testing device – no data entry is required. When the screening visit is complete, the nurse submits the results, all of which are automatically transmitted to your EDC system and other clinical systems. Additionally, stats about the nurse’s performance and her experience using the app are automatically transmitted (e.g., How long did it take her to move from step to step? How long was the overall visit? In which steps did she seem to struggle?). As the sponsor or CRO running the study, you see the individual nurse’s performance and use data, as well as aggregate data from a single site, multiple sites, and all sites in a study. This analytical dashboard allows you to identify positive and negative trends in the screening process, as well as potential issues that need to be clarified or corrected. Based on the data you see, you recognize that a particular question in the screening process needs clarification. You kick off a workflow to approve the change. Once approved, you make the change and release it for production use. Over time, you see the use data for that question improve. This is a popular approach to addressing the issue because it is easily attainable and clearly impactful. At its core, this solution reframes the site personnel who perform the screening process as customers, and then uses CX principles to provide them with a convenient and engaging tool for completing the process. It also comes with two rather pleasant side effects: it greatly reduces data entry error that can lead to erroneous screen failures and screen passes, and it provides insight into how to continually improve the overall screening process.
- A second approach that we see industry pioneers adopting works something like this: A potential clinical subject comes into a site for his screening visit. When he checks in, he is issued an iPad for use during the visit. On the iPad, he finds an interactive app that leads him step-by-step through the screening process. It moves him through questions dynamically, using a decision-tree format that adjusts based on his answers. When it comes to screening tests, the app moves him through a circuit of digital devices, each designed to perform different tests – a digital scale, a digital blood pressure machine, a digital toilet. When the potential subject has completed all of the questions and tests, he submits his results and returns the iPad to the front desk. All of his data is automatically transmitted to the site personnel and your EDC system. The data is then automatically analyzed and issued a tentative status of “pass,” which triggers a notification to the site investigator. Later that day, when the investigator has a moment, he reviews the potential subject’s results and approves his participation in the study. As soon as his status changes to approved, he receives a welcome notification and a request to complete the informed consent process. While this scenario might seem overly futuristic to some, we definitely see this happening, and all signs point to this being the direction the industry is heading. This highly digitized and automated solution significantly reduces the screening burden on site personnel and significantly increases the accuracy of the data collected during the screening process. It also more closely aligns with patient/subject expectations in the “Age of the Customer,” resulting in a more pleasant and engaging experience for them. Granted, this solution does take more effort to design and implement, but in the case of large-scale, long-term clinical trials, or of a particular site being involved in several of your trials over time, the return on investment (ROI) is clear.
- Dirty clinical data is one of the most costly aspects of clinical trials. Not only does the review and cleanup slow down time to market and increase development costs, dirty data can stall or even kill a new drug application (NDA). Consistently receiving dirty data from sites can seriously damage a sponsor’s or CRO’s relationship with a site/investigator, and can lead to a site no longer working with a sponsor or CRO, even though that site might have the ideal patient population, location, equipment, and/or expertise that the sponsor or CRO needs. This tension can be reduced by leveraging digital technology and the Internet of Things (IoT) in clinical data collection.
- We are seeing companies exploring this, dabbling in it, and even diving in head-first, including this scenario: After successfully enrolling in a clinical study, a subject is issued a wrist tracker and a digital skin patch, and is given login credentials for a proprietary app to download on his mobile phone and tablet. Over the course of the study, his wrist tracker and skin patch continuously collect and transmit data to his managing site and your EDC system. Additionally, the mobile app pushes him reminders to take his medication. One day, the investigator receives a notification that the subject’s blood pressure is running high, along with a prompt to ask whether he should be asked to come in for a visit. The investigator clicks “accept” and the subject receives a notification on his phone, along with the option to schedule his appointment online. He completes the scheduling process and makes his way into the site for his appointment.
- One of the most beneficial (and attainable) solutions we have seen that makes use of IoT technology is for subject diaries, including reminding subjects to complete their entries, facilitating their entries in interactive and engaging ways, and automatically mining their entries for potential adverse events. Consider this scenario: Once successfully enrolled in your study, a clinical subject is issued login credentials for a proprietary mobile app he downloads onto his phone. Over the course of his participation in your study, he receives push notifications to remind him to log periodic diary entries. In the app, he follows interactive prompts that ensure he’s submitting his diary entries completely and on time. The app even rewards him for doing so. His diary entries are automatically transmitted to your EDC system and other clinical systems. Additionally, the app makes use of the other functions of his phone to submit environmental data, such as exercise and sleep data. All the while, third-party contextual analysis software is monitoring his diary entries. One day, the investigator receives a notification that the content of one of the subject’s diary entries seems like a potential adverse event, along with a prompt to ask whether he should be asked to come in for a visit. The investigator clicks “accept” and the subject receives a notification on his phone, along with the option to schedule his appointment online. He completes the scheduling process and makes his way into the site for his appointment. The third-party contextual analysis software is an especially brilliant addition to the use of digital technology in clinical data collection. It goes above and beyond just ensuring accurate and timely data collection, and aids sites, sponsors, and CROs in the identification of potential adverse events in a way that only machine learning technologies can.
- Even the most promising clinical sites can have trouble recruiting enough eligible subjects. Pressure from upper management and/or the sponsor organization to meet recruitment targets causes stress and anxiety for study managers, which in turns strains their relationships with underperforming sites. This tension can be alleviated by helping sites: Broaden their pool of potential subjects Build a database of potential subjects Leverage the social networks of potential subjects for recruiting purposes
- To illustrate how companies achieve this, consider the following scenario: While surfing the web on his mobile phone, a young man receives an offer to apply to participate in a clinical trial. He thinks, “Why not?,” creates a user ID and password, and then follows a series of interactive prompts to build out his profile. While there are no current trials that are a good fit for him, he continues to receive occasional helpful tips for managing the conditions he included in his profile. Down the road, potentially after failing a screening visit, his profile is flagged as someone who is not himself a good fit for a new study, but as someone who might have people in his social network who are. So, he receives a request to spread the word to his network, along with ready-to-use tweets and Facebook posts. A few people in his network are interested and create their own profiles, just like their friend, and the process restarts for each of them. This modern, multi-faceted solution not only frees sites from the constraints of their existing patient population and physical location, but makes it convenient for potential subjects to become and stay engaged over time. It casts a wider net than any one site can, involves more parties (even automated parties) in recruitment efforts, and leverages customer experience (CX) principles to connect potential subjects to sites.
- This is one of the biggest complaints we hear from both sponsors/CROs and sites/investigators. Sponsors and CROs dedicate countless resources to researching and addressing payment questions and concerns raised by site personnel, and site personnel often feel frustrated, undervalued, and distrustful of sponsors and CROs that do not pay them as promised. When a site is not paid on time, is not paid correctly, or is not acknowledged in a timely manner when payment issues are raised, it can trigger a sharp decline in site productivity, which negatively impacts a product’s overall time-to-market. This negative outcome can be sidestepped by: Providing sites with a comprehensive history of payments that have been issued to them Equipping sites with self-service tools to open claims against payments that seem incorrect Giving sites the ability to see the status of open claims over time Automating claim investigations and resolutions, where possible and appropriate
- Here is one of the more thoughtful solutions we have seen that incorporates the above principles: An investigator running a study site logs in to see an overview of her payment history. Something seems off, so she begins to review each payment in detail, and comes across what she believes to be the source of the problem – the withholding for her first payment seems higher than what was agreed upon in the contract she signed. The percentage was corrected for all subsequent payments, but the original payment was never adjusted. Rather than picking up the phone, right there in the system, she opens a claim against the payment in question and selects “Withholding” as the type of claim. She fills out the other required fields and submits the claim; the status changes to “Submitted.” The field values the investigator selected trigger an automated resolution process in which the withholding percentage in the payment is compared to the details of the contract. The automated workflow is unable to resolve the claim because the contract contains two different withholding percentages, so your clinical finance team is notified that human intervention is required. A clinical finance staff team member picks up the claim, which changes the status to “Under Review” The investigator can see that someone is working on his claim. Your clinical finance resource works with your legal team to draft an amendment to the contract that clarifies the correct withholding percentage for the site/investigator and routes the amendment for review and approval. After receiving the approval from the investigator, clinical finance issues a payment adjustment for the initial payment; the claim status changes to “Resolved.” Once the investigator receives the payment adjustment, she clicks the “Accept Resolution” button for the claim, and the claim is closed. While it does take time and effort to map out the automated workflows for investigating payment claims, you can see the incredible value in doing so. The issue of payment problems is so prevalent in the industry and so detrimental to site/investigator productivity and relationships, that we see companies making this particular solution one of their top priorities.
- At first glance, having outdated contact information for sites might seem like a pretty minor issue. But when it results in delays related to required documents, monitoring visits, or clinical supplies, the issue quickly becomes more serious. It is easy to keep a sponsor or CRO in the loop when a shipping or mailing address changes or when a site coordinator goes out on maternity leave and the interim coordinator should now receive all phone calls and emails. But it is usually not top-of-mind for sites, which can lead to a lot of frustration and rework for the sponsor/CRO. This strain on the site relationship can be avoided by: Empowering sites to see the contact information on file for them at all times Providing sites with self-service tools to update their contact information Periodically prompting site personnel to verify their contact information on file
- Implementing this kind of solution is simple and effective. Consider this: Every six months, the site coordinator receives a push notification on her mobile phone to verify that the contact information on file for the site is correct. During her review, she notices is that the address you have designated for shipping is out of date. Their medical campus now has a centralized shipping and receiving location that’s different from the office where they see patients. She makes the update and submits the changes. The system automatically verifies the address with the US postal service as being valid, and goes on to check your CTMS to see if the address exists, but has not yet been associated with the site. Because the system is unable to find an exact match, you are alerted that a human needs to weigh in and make a decision. You review the content of the update and verify that the address is not a slightly different duplicate of an address already in the system. You accept the change, which creates a new address and associates it as the shipping address for the site in all of the integrated systems, and then updates the change request status and notifies the site coordinator. This simple, yet powerful, solution’s strengths are transparency, self-service, and automation. Just think about how something like this could help your organization avoid communication and mailing/shipping issues with your sites. Now, for the issue you voted as your #1 concern…
- Keeping sites in compliance with their required documents is an ongoing battle for every sponsor and CRO. Considering the volume of documentation involved in a clinical trial, it is no wonder why sites struggle to stay on top of it, or why sponsors and CROs get frustrated when auditors issue findings against them because their sites are out of compliance. This frustration can be lessened by: Providing sites with greater visibility into their document compliance status Automating notifications related to upcoming and past-due document deadlines Enabling easier document reviews, approvals, and sharing back and forth
- Here is an effective solution we’ve seen for this issue: The site coordinator receives a notification that her CV on file will expire in 30 days. She doesn’t have time at the moment to address the issue, and then accidentally forgets. Two weeks later, she receives another notification about her CV. Since the issue is more time-sensitive, you also receive a notification. Following the second notification, she makes the time to update her CV, and then uses the link in the notification to log in. She finds her current CV on file, uploads the new version, and submits. You receive a notification about her activities. She’s able to follow the status of her newly uploaded CV over time, so she knows that you’re taking action on her submission. The next time she logs in, she can see that all of the site’s documents are in good standing, including her CV. This approach empowers sites to manage their own document compliance status, makes it easy and convenient to do so, and reassures them that sponsors/CROs are supporting their efforts. You would be amazed how much something so simple can improve relationships with site coordinators.
- That brings us to the end of our countdown, so I wanted to briefly mention a couple of ideas for where you can go from here. If you feel confident that some or all of the issues we discussed today apply to your organization, and you’re interested in seeing the solutions we described in action, just shoot me an email. We’ve built a number of site-facing applications to solve these types of problems and would be happy to share them with you. On the other hand, if you’re not really sure about the root of the struggles you’re having with your clinical sites, the first step is to conduct the research to find the answers. We’re actually in an engagement right now that centers on this very topic – helping a sponsor organization better understand the “customer journey” experienced by their preferred investigators, and then build out a strategy and roadmap for improving that experience.
- With that, I’ll turn it back over to Eugene to touch on these additional resources, and then you’ll see my email address on the final slide. Eugene?
- Since this is just a 30-minute webinar, we don’t have time for live Q&A today, but you are welcome to email me directly with questions or comments. If you don’t have time to jot down my email address right now, fear not – all attendees will receive a copy of this webinar, including the slides.