5
Feb

San Diego Clinical Research Network – Conference Takeaways

Clinovo’s Chief Technology Officer Marc Desgrousilliers was invited to discuss Cloud technologies on behalf of Clinovo at the 2014 December edition of the San Diego Clinical Research Network (SDCRN). Alongside representatives from life science companies Thermo Fisher Scientific and Neurocrine Biosciences, Marc presented his vision of Cloud Computing and how it affects the Life Sciences and clinical trial industry. Here’s a summary of the key points discussed during the conference.

In which capacity do Cloud technologies improve data capture and quality 

All speakers agreed that digital data is growing exponentially worldwide and that it is deeply impacting Cloud technologies. A significant amount of data is generated each day which has led to the overall amount tripling during the last 3 years. In 2020, the overall amount of global data is expected to reach 40026 Exabytes (Billions of Gigabytes). This is a great opportunity for clinical trials and overall science experiments as they can be run from anywhere in the world using the latest and most advanced technology.
This next figure demonstrates the projected spending amount for Cloud computing in the global healthcare market. This significantly increasing forecast testifies of the Cloud computing trend in the life science industry and the benefits attached to it.

Total spending on Cloud computing

As of right now, an important amount of time and resources goes into the maintenance and management of the software in order to ensure data collection transcription and relevancy.
Taking advantage of the Cloud technology is a great opportunity for the life science industry. It ensures a reduction in the maintenance overhead needed for utilizing technology, and, in addition, reduces manual data collection. This lean management approach ultimately results in less human errors and therefore higher data quality. Processes can now be automated in order for scientists to spend more time in their research projects, advancing discovery in a more streamlined and expedient process. The IT infrastructure to handle the growing amount of data would also be significant for companies whereas Cloud technologies offer a very cost-effective alternative.

Automated technologies with the Cloud

While every stakeholder agrees upon the fact that Cloud technologies improve the overall clinical trial process, its implementation still represents a hurdle. There is always a discrepancy between the marketing vision of the Cloud and what it actually means on a technical level.

Cloud computing allows for on-demand access to a shared pool of resources that can be done with little effort or time. Cloud technology can be summarized by these 5 characteristics:

  1. On-demand self-service
  2. Network access
  3. Service level agreements
  4. Resource pooling
  5. Elasticity

While more and more EDC solutions adopt Cloud technologies, choosing a Cloud-based EDC solution however requires even more precaution. Indeed, buyers need to make sure the system they’re looking at meets the regulatory compliance. Without this, they will not be able to ensure validation to support their clinical trial. Decision makers need to evaluate the EDC vendor and data safety by asking for proof of validation documentation, support for their hosted application, and data encryption and security measures in place.

Evaluating and choosing EDC systems

Choosing the right EDC vendor remains the final step in the adoption of Cloud for clinical trials. This part is obviously crucial and therefore requires time in order to thoroughly evaluate the best vendor for your clinical trial. Many vendors have described this step from a technical point of view, which clearly represents a major point of interest for the buyers, but vendors often forget the end user’s perspective. Indeed, the GUI and overall user experience is an essential topic that vendors should not put aside.

Another factor in the decision making process is the time and ease of implementation.These points are often underestimated by the buyers but the kick-off training length varies greatly between the vendors. ClinCapture, for example, requires a 2-day training program whereas other EDC systems require a whole week.

Overall, the benefits of Cloud-based EDC systems can be summarized in the following: Increased transparency between the stakeholders and real-time overhead into clinical trial operations and data, further communication and collaboration between investigators, sponsors, and partners. enhanced efficiency and reduced speed to conduct trials and cost-effectiveness. While the perks are clearly identified, choosing a system and implementing it still represents a barrier-to-entry that vendors need to tackle.

Co-authored by

Marc Desgrousilliers – Chief Technology Officer at Clinovo – marc@clinovo.com

Joshua Elvert – Business Development Manager at Clinovo – joshua.elvert@clinovo.com

7
Oct

Key Takeaways from Outsourcing in Clinical Trials Conference

My colleague Joshua (Associate, Business Development) and I attended the Outsourcing in Clinical Trials (OCT) Conference in San Diego on September 24th and 25th, 2013. I have to say, the events put up by the Arena group are extremely valuable and the speakers are of excellent quality. These events are of particular interest to Clinovo, as they address the best practices for successful Sponsor/Contract Research Organization (CRO) collaboration. I don’t think anything I heard was new or revolutionary, as I believe that at Clinovo we always strive to follow the principles the speakers outlined, but it never hurts to reiterate them.

Here are some of my key take-aways:

  • Set up expectations that are mutually agreed upon by both parties: It is important to define expectations that both parties understand and agree on in order to avoid bad surprises down the road. I would add to this: define clear responsibilities. Your CRO needs to follow through and be held accountable for what they are responsible for.
  • As a Contract Research Organization (CRO), never promise what you can’t deliver. At Clinovo, we consider this a principle of particular importance. A successful relationship relies on trust, and that implies complete transparency on what one can deliver in what timeline. Before we give our milestone-based plan to our clients, we always check internally that the team is able to deliver what is outlined in the plan, and on time.  Additionally when a problem arises, a CRO must be transparent with the sponsor and discuss the issue with a proposed resolution.
  • Include all vendors at the kick off meeting. I had never thought about inviting all vendors to our kick off meetings, but it makes complete sense. Vendors are in pursuit of the same end-goal; delivering the highest quality to their customers, and contributing to bringing medical innovations faster to patients. Therefore, getting to know your counterparts and aligning goals is instrumental for a fruitful collaboration.
  • Plan the unexpected. You should always prepare a mitigation/risk plan. What happens if enrollment doesn’t start on time? Plans need to take into account what to do if things go wrong, and be detailed enough for anybody to take over if necessary.
  • Choose a CRO that is truly integrated to your team. Sponsors and CROs need to practice cooperative, strategic planning. As we all know, 1+1=3. Vendors are in the same boat as their clients, and will only deliver higher quality by truly understanding in depth their customers’ needs, processes, and values. Being fully integrated is key to a successful clinical trial.

I also wanted to share a great talk from SynteractHCR on how to select your optimum Electronic Data Capture (EDC) system. Below are 7 insightful recommendations:

  1. Develop high level requirements with all stakeholders – It’s hard to get everybody’s input, but try.
  2. Separate your requirements into must-have and nice-to-have.
  3. Avoid subjective requirements (e.g. nice GUI): It has to be something that is quantifiable that you can test.
  4. Determine which companies are likely to invest more in development and expend their EDC solutions.
  5. Look at your vendor’s system roadmap.
  6. Understand how the EDC system can integrate with other systems.
  7. Check reference accounts.

I want to add that, in the end, it all depends on your internal needs. There is no one magic solution or system out there that works for all sponsors. There are many considerations to take into account when choosing an EDC, including budget, resource capacity, the complexity and length of the clinical trial. So at the end of the day, it’s all about how your vendor integrates to your team and how your system is suited to your requirements.

Sophie McCallum
Director of Operations, Clinovo

 

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