#FromKCRMailbox

The KCR Mailbox is a new, multi-part Q&A series featuring KCR experts’ responses to frequently asked question about industry hot topics. KCR leaders will respond to an email by detailing their opinions.

Irena Lambridis, Director of Quality Assurance & Compliance:

Q: Clinical trial technology is constantly changing, how do you ensure that QA procedures are keeping up?

A: As clinical technologies are evolving to become more effective and efficient in the clinical space, it is critical for Quality Assurance to carefully monitor and understand the expansion of these technologies, then fully evaluate the impact of operational and technical changes on the quality processes that govern these applications, tools and processes. Considerations are given to use of new systems and/or engagement of new vendors that may require real time categorization of vendor risk followed by appropriate qualification and documentation by QA of a vendor’s risk profile. QA should remain on the forefront of assuring a quality perspective in every aspect of technical systems that support clinical operations when brought into an organization. In today’s world, this requires pre-defined, cyclical evaluation to ensure all technical advancements are appropriately qualified for their use.

Anja Urban, Associate Director of Project Management:

Q: How does technology enable more efficient project management?

A: Using Technologies like Veeva Vault Clinical (VVC) or Veeva eTMF greatly supports maintaining oversight of the study, its quality and all ongoing activities.

This starts when the Project Manager (PM) plans study milestones, allowing any other study team member or client to be updated in real time without the need for additional emails and files circulating within the study team. For example, planning Site Initiation Visits will support more efficient resource planning because once the visit is planned in VVC, it automatically triggers expected documents in TMF, allowing the PM to know exactly what should be filed and when. This enhances study speed and enables greater oversight on study quality.

Additionally, when Site Initiation Visit reports are written in VVC, it is automatically filed in the eTMF after finalization. This allows the process to managed within one system from start to finish and to be completed in a shorter timeframe. And let’s face it, filing documents in the Trial Master File on time is difficult but critical for being inspection ready.

When it comes to planning milestones and necessary study actions and communications, all can and should be captured in the CTMS. Communicating through the CTMS allows full visibility and traceability of ongoing activities and helps identify potential challenges. It also greatly reduces e-mail communication which everyone can appreciate.

However, technologies are only as helpful as the quality of their maintenance; when correctly operated, the advantages are clear and supportive for more efficient project management.

Natalia Sciechowska, Regulatory Manager:

Q: What is your biggest takeaway from the Rotation Program Participation?

A: Participation in the Rotation Program definitely expanded my perspective on clinical trial start-up processes and helped me look at this system from a broader lens. The more you understand how different procedures work, the better you are able to plan and mitigate risks in a given project. Such changes also bring opportunities to be a part of a new team and learn something new from all of its members.

It also showed me that there are other aspects of clinical trials, aside from Site Contracting, that I knew very well, that I enjoy and Regulatory is now one of them. The “unknown” is always challenging, but it’s also exciting. One of the benefits of the rotation program was gaining a different perspective on cross-departmental processes. It allowed me to notice things and correlations between departments and procedures that were not visible to me before.

Iwona Kiezun, Head of HR & Adm:

Q: Why Developing Company Culture is so important today?

A: After a year of social distancing, lack of F2F meetings, and working from home experience, company culture and the value we place on it has changed immensely.

Strong company culture has traditionally been prioritized so organizations can attract and retain high quality candidates and employees; this remains true. In the past, cultural practices in the workplace tended to revolve around perks like group outings, casual dress days and extra snacks in the break room. While these are still fun and important to some, having a strong sense of community and clearly defined culture has been the key to navigating the pandemic for a company like ours.

With nearly all our employees working remotely and in isolated situations at home this year, we wanted to ensure that they still felt connected and understood without the face-to-face interaction. KCR implemented surveys and frequent check-ins to better understand their feelings during when performing their duties remotely. Thanks to these surveys we have learnt how important is being in regular contact with others, and that maintaining work-life balance helps stay focused and productive. Prioritizing company culture and employee well-being before things got difficult helped ensure that our teams trusted our leadership and truly believed that we had their best interest in mind. This allowed them to feel comfortable voicing their feelings, good and bad, so that we could take appropriate actions to care for our teams. This is priceless.

Agnieszka Felicjanczuk, Legal Counsel:

Q: What influence has GDPR made on the clinical trial industry since being introduced?

A: We are approaching GDPR’s 3rd anniversary in May. Did it bring a revolution in clinical trials? Definitely no. In such a data-driven industry, personal data has always been treated with the utmost care. What has changed, is the need to implement additional documentation, include certain clauses and record personal data flow. We all got used to this.

You may remember that one of GDPR’s goals was to introduce unified rules for personal data processing in the EU. When conducting an international clinical trial, you have the opportunity to observe how different countries apply different approaches to certain topics. Taking the roles of controller and processor as an example — there are some countries like Germany and Bulgaria, where Ethics Committees consider the study sponsor and the site as joint controllers of patient data. There are other EU countries where no clear standard has been shared. In these countries, you may come across different approaches from sponsors or study sites including investigator, site and sponsor being separate administrators. Additionally, sites may not want to conclude the DPA, as it claims to have nothing to do with personal data arising from a clinical trial. The roles of the sponsor, investigator and site may be regulated differently in some countries — this is why it is important to consider country specifics while designing a clinical study and personal data flow. Concluding: I would still hope for a harmonized approach in the EU on how GDPR identifies the controllership roles of various parties in a clinical trial.

The other topic worth mentioning is personal data transfer outside of the EU. For many U.S. sponsors, it has been a challenge to secure the transfer of the study results from EU to the U.S. Once everyone applied their preferred security measures, the Shrems II ruling forced many companies to revisit their strategy. We are all waiting for the new EU standard contractual clauses, as that should help in solving this problem.

Douglas Bain, Chief Technology Officer:

Q: What advantages does KCR have when it comes to implementing a next generation cloud Digital platform?

A: KCR is large enough to achieve a global reach with our sponsors, sites and patients. At the same time, we are small and agile enough to make changes quickly. In 2021 and beyond, agility in being able to respond to changing research settings is critical in drug development success. As a simple example, in early 2020 we decided that we should switch to a digital eFeasibility solution. This would streamline and simplify the process of carrying out feasibility assessments with the large number of sites we work with. This project was defined in January and fully deployed by April. Within the same year, we iterated to a Version 2 of our solution that automated CDA handling and standardized the database produced from study to study. This method was applied to all KCR studies within a matter of months. The same applies to the other technologies we implement, whether it is the latest trial management, Direct to Patient or remote monitoring. We are able to demonstrate that we can work with the best technologies, such as the Veeva Vault Clinical suite, paired with the highest quality agile work methods to deliver efficacy research for our sponsors.

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This series will feature blog submissions from a variety of KCR leaders on industry news, hot topics and all things clinical research.

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KCR CRO

KCR CRO

KCR is an international clinical development solutions provider for the bio-pharmaceutical & medical device industries.

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