Guide to Streamlining Study Startup

Dana Kudrnova from Novotech shares proven strategies to accelerate study startup by overcoming regulatory and administrative bottlenecks. Learn how data-driven KPIs, mandatory templates, and unified technology transform unpredictable timelines into streamlined milestones. Dana emphasizes that while AI provides speed, active ownership and human oversight are what truly prevent document delays. This episode highlights why proactive communication between CRAs and sites is the secret to surfacing issues early and moving from site selection to first patient dosed more efficiently.

Transcript

Michael Pierre 0:00

Greetings everyone, and thanks for being a part of the Society for Clinical Research Sites on SC RS Talks. Get ready to dive into pressing clinical research industry topics, celebrate achievements, and create a deeper connection within the research community. This is the space to amplify voices and perspectives that shape the landscape of clinical research. Our guest today is Dana Cordova, the director of European Study Startup at Novotech CRO. Before we get into some questions, Dana, why don't you tell us a little bit about Novotech and what you do there?

Dana Kudrnova 0:36

Thank you for having me here today. I truly appreciate the opportunity. My name is Dana Enova. I'm director of European Studies Startup at Novotech, and I'm based in Prague, Czech Republic. A bit about my background. I graduated from the University of Chemistry and Technology with focus on macro neurochemistry. I initially work in different industry, and about 18 years ago, I transitioned into clinical research. Over the years, I have grown from CRA to project manager and project director. I have experience with both drug and medical device studies across wide range of indications, collaborating with large pharma as well as small biotech companies. In my current role, I oversee feasibility, regulatory, and contracts departments in Novo Europe. Novo is global full service CRO that begin as an Asia Pacific CRO and expanded globally through strategic partnerships with CROs in other regions. And following a decade of working together under partnership model, Novotech has incorporated the European CRO into its organization, enhancing its global presence. It's great company to be part of, and I'm very happy to be here with you today.

Michael Pierre 1:56

Alright, and thanks for joining us. So. Our topic today is study startup. So where do the most significant study startup delays occur, and what key performance indicators help identify them

Dana Kudrnova 2:12

well in startup, our primary timeline and really our core objective in clinical trial is to reach first patient screen, and first patient dosed. These milestones mark the end of startup phase, but getting there requires a long chain of activities to fall into place. We begin with feasibility and selecting the right sites. Then we move into collecting documentation, preparing regulatory and ethics submissions, obtaining approvals, negotiating contracts and budgets, training site staff activating the sites, and finally supporting teams in identifying and enrolling suitable patients. At any point of the sequence, delays can occur and it's often not easy to identify which one is the most significant or critical.

Michael Pierre 3:01

Yeah,

Dana Kudrnova 3:02

some can be operational or administrative, like missing documents, institutional approval steps, longer contract and budget negotiation, signature bottlenecks or delays with third party vendors. Other delays can be related to regulatory. This includes challenges with ethical committee and regulatory author submissions, or simply just waiting for essential study documents like Protocol Investigator Brochure, IMPD or QP Declaration Naec works in CTIS and non CTIS countries and our regulatory teams understanding nuances of each systems, providing guidance to help clients obtain approvals efficiently. What's important is that many of these delays follow predictable patterns across countries and sites. So when we understand we can anticipate risk and build realistic timelines and target medication where it truly matters, it's a key part of our overall risk management approach. And this is exactly where KPIs come in. KPIs help us move from assumptions to data. They allow us to monitor timelines, identify delays easily, and see how efficiently our processes are running. Because our KPIs are consistent across regions, we can compare performance, identify trends, and drive proactive improvements at novatech, our KPIs follow site and country level milestones. For example, site selection, ethic committee and regulatory authority submission approvals, site initiation visit, and site activation. For contracts and budgets we track the full cycle time from the first version to final executions. And these metrics give us clear visibility into where bottlenecks occur and where support is needed to keep startup moving.

Michael Pierre 5:09

Before I, get into the next question, Dana, what is the average contract turnaround time that you all see there? Just for my own interest,

Dana Kudrnova 5:20

it depends on the country and depends on the site.

Michael Pierre 5:24

What's a quick country?

Dana Kudrnova 5:28

The country, is for example, non CTIS country is Georgia. They are quite big.

Michael Pierre 5:35

Alright, thanks for that answer. What's one practical change that could streamline contracts and budgets?

Dana Kudrnova 5:44

I believe the greatest opportunity to improve contract negotiation efficiency lies in implementing mandatory contract templates, which can significantly shorten turnaround times. Several countries in Europe, like uk, France, and Italy already operate with mandatory templates. Others, for example, Czech Republic, have recommended country template and some still rely on site specific contracts in some countries. We also have mandatory budget templates, which can further accelerate negotiations and we are starting with contract negotiation just after confirmation of site selection. One practical step that was implemented. Invotech is gathering information from sites upfront through the clinical trial agreement questionnaire. This questionnaire gives us all the key operational and administrative details that influence how fast we can move through contract and budget negotiation with each site. It gives us the clarity to plan, anticipate risk, and keep negotiation moving efficiently. It may be seen as additional burden for side, but providing information upfront, we are gaining time and prevent delays later in activation. Overall, there are few core practices that can greatly simplify the negotiation process. First. Truly understanding each country's and each sites, the pick on negotiation approach allows us to anticipate requests rather than to react to them. Also, using standardized contract and budget templates, prevent sites from renegotiating feder, additional elements in every study, agreeing early on common cost ranges, reduce unnecessary back and forth, and finally, keeping all parties aligned on requirements and true steady progress. None of this, it's extra work. They simply remove available delays.

Michael Pierre 7:45

So which technology or workflow has proven most impactful for accelerating startup?

Dana Kudrnova 7:53

For me, leveraging technology in startup really comes down to keeping everyone aligned. When teams work in one shared system like Veeva, Salesforce, or other, they get real time updates, access the same information, understand the next step and benefit from automation of repetitive tasks. That clarity and coordination is what truly creates speed. The reality is that technology only accelerate startup if people actually use it. Many teams struggle because, their work is scattered across multiple tools. To move fast, you need to commit to one shared system, build simple daily habits around it and automate the basics. Technology doesn't create alignment on its own people. Do the tools simply make it easier and faster? So using technology doesn't mean any complexity. It means creating clarity and bringing our studies to startup readiness and more efficiently, quicker, with higher quality. And of course, one of today's favorite topic is ai. Everywhere we turn, people are discussing artificial intelligence and how it can support the daily work, streamline processes, and even help us spot things that might otherwise go unnoticed. It's exciting space and I fully understand why it captures so much attention. But, with all this enthusiasm, it's equally important to stay grounded. Any information generated by AI still requires the human review at least a simple sanity check. We all know that AI is not 100% accurate. It can be incredibly helpful, but it can also make mistakes, misinterpreted context, or even confidently produce something that is entirely incorrect and beyond accuracy. There is a very real need to stay mindful of confidentiality and data protection. AI should support us not put our sensitive information at risk. And that's exactly why many companies are now investing in building their own internal AI tools solutions tailored to their workflows, their data, and their security frameworks. These tools are designed to provide the benefits of AI while ensuring the right level of control and governance. Personally, I believe that technology, including AI, will continue to play an increasingly important role in our work. It won't replace our judgment, expertise, our responsibility, but it'll help us work smarter, analyze faster, and focus our energy. Very truly matters and as long we use the thoughtfully and responsibly it can be great ally in moving our work forward.

Michael Pierre 10:52

And so from your perspective, what is the first bottleneck or what's the first thing that sites could do or address so that they could see immediate improvements in their contract timelines?

Dana Kudrnova 11:09

During startup bottlenecks can appear at absolutely any step, and often there isn't just one single delay to fix. It's really as simple as saying, this is the problem. More often delays overlap. They influence each other and they shift depending on the country, the site, or even the individual stakeholder involved. So when I talk about this, I like to use simple analogy from the airport. You know the announcement we've all heard a hundred times. Please do not leave your luggage unattended. It's very straightforward message. If you leave something unattended, it becomes a problem. The same principle applies in startup when a bottleneck appears or even before it appears. We cannot afford to leave anything unattended, every document, every timeline, every open task needs active ownership. We need to follow up, revisit it, check its status, and make sure it's moving because moment we assume that someone else is taken care of. It's exactly when delay start building. It can be missing signature, slow feasibility response or documents stuck in someone inbox. Addressing it easily and consistently prevents small delays from turning into major brokers. And this consistent, proactive approach is what truly makes the difference in startup timelines. And of course, other essential point is strong communication between CRA and the side. Aligns expectations, speed up issue resolution, and builds trusting working relationship when both sides stay connected. Sites feel supported rather than alone in the process, and are more willing to reach out to CRA early with questions or concerns. So my advice to sites is, please don't hesitate to reach out to our CRA. This helps surface issues before they impact timelines and get us to the first patient in safely and on time.

Michael Pierre 13:23

Okay. Yeah, I did contracts for many years and I think that, you know, to your point, a lot of contracts are delayed because people put off working on them as quickly as they can. They say, I'll just get back to that person on Thursday or something. It's very interesting dynamic there. Well, thank you very much Dana. Very nice to meet you today. so, to our listeners as we wrap up, please don't forget to explore more site focused resources on our website, my scrs.org, you will find a wealth of content and publications plus the opportunity to save your spot for upcoming webinars and SCRS summits held throughout the year. Thank you for tuning in, and until next time, we will see you then. Bye-bye.

Dana Kudrnova 14:10

Thank you very much for having me here today. It's been a pleasure.