Productivity Improvement Cost-Effective CER- Webinar Q&A - Shruti Sharma

Productivity Improvements for Cost-Effective CER Writing and Maintenance – Q&A

Celegence, a Global Regulatory Affairs Services & Technology company for the Life Sciences Industry, hosted a webcast in March 2022 titled “Productivity Improvements for Cost-Effective CER Writing and Maintenance”.

By reading the Q&A session you will have an opportunity to get a first-hand look at the ground-breaking functionalities of our technology platform CAPTIS™ and learn how CAPTIS™ can improve your organization’s compliance with MDR & IVDR.

We are here to address any other questions that you may have related to the webinar, or questions about how you may be able to benefit from our MDR and IVDR compliance technology CAPTIS™.

This post contains the Q&A session from the webinar – giving you the answers to the most common questions that were asked about CAPTIS™ Technology Solution.

A full transcript of Shruti’s presentation is available to download (and to read below). 

EU MDR - Checklist - Celegence Life Science

Claim Your Free EU MDR Checklist Now!

Make sure you and your business are compliant with the new EU MDR. Get our 23 page checklist for actionable technical documentation requirements.

GET YOUR CHECKLIST NOW
EU MDR - Celegence Life Science

Claim Your Free EU MDR Checklist Now!

Make sure you and your business are compliant with the new EU MDR. Get our 23 page checklist for actionable technical documentation requirements.

GET YOUR CHECKLIST NOW

Q: Can I configure my own questions for exclusions on CAPTIS™?

A: Yes. You can configure all your own questions. Whenever you set up your project for the first time on CAPTIS™ you can configure the list of questions that you want for L1 and L2. CAPTIS™ also allows you to set templates meaning if multiple CERs or multiple literature reviews follow the same exclusion reasons you can set the template just once and every time when you start a new project you can load the template so you don’t have to enter those questions again.

CAPTIS - CER - Cost-Effective Writing Maintenance

Q: Can I reuse the state of the art (SoTA) literature from one project to another on CAPTIS™?

A: Yes. If you have conducted the state of the art (SoTA) literature review on CAPTIS™ then you can clone an entire project. For example, If you have a Device A for which you finished the SoTA review and then if you have a Device B which is also from the same therapeutic area which may need some contents from the other SoTA for the other device then you can clone project A and then you can edit the date range and all the answers that you have taken so far all of them will still remain. The extra articles which came up in the gap during the date range  will be updated as pending articles. So yes you can leverage the whole search.

EU MDR - Checklist - Celegence Life Science

Claim Your Free EU MDR Checklist Now!

Make sure you and your business are compliant with the new EU MDR. Get our 23 page checklist for actionable technical documentation requirements.

GET YOUR CHECKLIST NOW
EU MDR - Celegence Life Science

Claim Your Free EU MDR Checklist Now!

Make sure you and your business are compliant with the new EU MDR. Get our 23 page checklist for actionable technical documentation requirements.

GET YOUR CHECKLIST NOW

Q: How many people can access a project at once within CAPTIS™?

A: CAPTIS™ is designed with collaboration in mind. We want cross functional teams to be able to use the platform at the same time and also exchange information, that is why we haven’t followed the user based subscription model rather it is a project based subscription model. So you can have any number of users access the same project on CAPTIS™.

Q: Can I generate article summaries on CAPTIS™?

A: Yes. So at the L2 stage where we saw the entire PDF, you can set up summary tags which are the same as your column headings for your tabular summaries. You can have text boxes which come up every time you review in full-text in L2 and you can summarize your article there itself.

Q: Can I change my date range after I perform my review on CAPTIS™?

A: Yes. You can change the date range even after you completed the entire review. For example, you have a date range of 5 years and you want to shorten it to 4 years. You can do that and all your previous answers  will remain. If you want to expand the date range then all your previous answers will still remain again and you will only get the new articles which came up in the gap search. So you have to only take actions against the articles which came up in the gap search, the newer articles.

Q: CAPTIS™ is the new technology developed by Celegence at the moment. What will be the 1 main benefit of CAPTIS™?

A: Personally I use CAPTIS™ for lot of my systematic literature reviews. I was doing the literature reviews even before technology came into the picture. I have been doing the manual processes and I don’t think I can ever go back to working on excel sheets. The amount of efficiency by using technology in general brings to your entire process. The amount of time I save by not having to manually look for data and not having to manually collate it. Also, I can have separate workflows for my state of the art and for normal safety & performance searches and even if I want to shift articles between both of these workflows, it’s so easy. I don’t have to keep track of any data anymore. These are the main benefits of CAPTIS™.

MDD Review - CAPTIS Technology EU MDR IVDR Compliance

Q: What if the previous MDD review was not conducted on CAPTIS™, how do we manage the overlapping dates in that case?

A: Even if your MDD search was not conducted on CAPTIS™ you will be able to import the entire review into CAPTIS™. You can export your entire literature review to CAPTIS™.

Q: Why did we exclude the literature after the first screening?

A: Systematic literature reviews are done typically in 2 stages – L1 & L2. L1 is where you are only looking at the title and abstract and making a call whether something looks relevant to you or not. You would not want to look at the full-text of all the articles because that will take up a lot of time and that is not efficient. Doing 2 levels of review will help you to get your final list of included articles faster and also, it is more efficient.

Q: Can I modify the tags mid project?

A: Yes. Even if you have configured the project you can always go back to your settings page and make any new changes. Any new exclusion reasons you want to add, any new project tags, any new highlights you want to make you can do everything. But if you change any existing reason, the reason which has already been used as an exclusion for one of the articles would go back to the pending stage. Just to make sure that we don’t have any errors in the final report that we generate, that is why CAPTIS ensures that we go back to the pending stage for any reason that has been edited.

Ways to Utilize CAPTIS™

There are different ways you can utilize CAPTIS™. Now we offer an in-house model where your team utilizes CAPTIS™ for all your in-house medical writing needs. You can also have a collaborative model where your team and our medical writers collaborate on projects and communicate via CAPTIS™, or you can outsource your entire medical writing projects where our medical writers can create your reports on your behalf, and you will get full visibility and review options on the platform.

Schedule CAPTIS Demo - Celegence

Schedule Your CAPTIS™ Demo

Due to demand and interest from the industry, we have devised an easy onboarding process for new clients migrating away from other solutions to CAPTIS™.

If you want more information on CAPTIS™, or if you have any questions on harmonizing your current process to the platform please contact us online or email us at info@celegence.com, and our team will be happy to set up an in-depth demo.

If your organization requires assistance with MDR compliance our team is here to help. You can reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device services.