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How does Datacapt assist CIDP in transitioning from paper-based to digital clinical trials?

“Clinical trials deserve the highest level of integrity, and Datacapt can be the solution that gives this assurance, in a user-friendly and flexible manner. There is no reason not to switch from paper for efficacy/tolerance cosmetic studies.”

Antish KowlessurSenior Data Manager

18+

Years of experience

100+

Studies per year

40%

time-saved

100%

control and visibility

Who is CIDP?

CIDP is an international CRO with over 18 years of experience in clinical research. With a strong foothold on each continent and centres located in Brazil, India, Mauritius, and Romania, CIDP has not only expanded geographically, but has also branched out into new sectors, and new clusters of activities.

The services provided by CIDP are segmented as follows: Research & Development activities, Preclinical in vitro and ex vivo testing, Clinical Research (Cosmetics, Pharmaceutical, medical device, and Nutraceutical), Biostatistics and Data Management, Regulatory Affairs, and Scientific and Medical Writing. The company is ISO 9001:2015 certified and is also CIR accredited.

CIDP has made the switch with the 3 modules eCRF, ePRO, and eConsent.

Before Datacapt

  • All data collected had to be transfered electronically to Mauritius

  • Complex nature of processes using Excel spreadsheets and data double-entries

  • Tedious quality system in place for traceability and management of queries

  • Heavy paper logistic (consents, CRFs, Questionnaires, and daily logs)

With Datacapt

  • Visibility on all the studies undertaken within the group

  • Better time management: data entry and query management have reduced considerably

  • Centralized and secured platform that helped them elevate the integrity and trust of their sponsors.

  • Sustainability Goals reached by providing more environment-friendly solutions

Challenge

CIDP's challenges

The Data Management and Biostatistics department of CIDP is located at the headquarters in Mauritius. As such, all the data generated for studies conducted globally must be transferred electronically to Mauritius.

Prior to the implementation of the Datacapt tool, CIDP’s team was using mostly Spreadsheets (such as MS Excel) for the management of the study data. This option had several challenges, mostly related to the complex nature of the processes and the requirement of having double data entry of all records with adequate quality control measures in place. Routine follow-ups were required with subsidiaries to clarify queries.

”We used to have a lot of paperwork (consenting, CRFs, Questionnaires, and daily logs), which is relatively tedious to manage, coupled with constrained space management and archival responsibilities.

Nusayha SokeechandManager-Biostatistics

The need for change was felt

As part of its digitalization ambitions, CIDP enumerated a series of measures for implementation that would add value to the clinical trials being conducted in terms of efficiency, robustness, and sustainability. More so, with the ‘natural’ change in processes brought in by COVID-19, it became important for CIDP to consider the implementation of a cost-efficient, robust, easy-to-use, remote-friendly, feature-rich, and easy setup & maintenance tool.

They needed a tool that would not compromise on the existing quality standards of the data generated during clinical trials, but rather, help them elevate the integrity and trust of their sponsors. And at the same time, they needed a tool that would help them achieve Sustainability Goals by providing more environment-friendly solutions.

And Datacapt meet those requirements!

”It was beneficial for CIDP to consider the use of Datacapt solution for the efficient management of data generated during the conduct of clinical trials.

Muzzammil HosenallyLead Consultant in Biostatistics

The solution

The choice of Datacapt for a complete and secured platform

As an integrated all-in-one platform, Datacapt offers many advantages. Firstly, the fact that the tool provides a platform that can pool all the studies undertaken within the group was game-changing for CIDP. In addition, the data is accessible 24h/7 from any region of the world.  The 3 modules, eCRF, ePRO, and eConsent allow the team to create forms, share with colleagues, collect data, and review them in just a few steps, and everything is saved in a single solution.

A smooth implementation

The initial implementation involved testing the platform in a real clinical study. This step enabled the team to test and verify if it was meeting their requirements.

The implementation of Datacapt was warmly welcomed by the process owners (administrators, end-users, IT, and sponsors) who were all convinced of the value of the implementation of such a platform. The smooth implementation of Datacapt has also proven that the learning curve was not too steep.

Various awareness and training sessions were organized by CIDP to give the end users an idea of the key features of the platform and the principles of passwords, login, etc.

With the complete integration of this cloud-based EDC solution within CIDP’s processes, the job profile of the data transcription team was revised to Data Managers, presenting a growth opportunity for staff members.

”Having a single main point of contact within Datacapt has proven to be very efficient. A partner that listens to our needs and addresses any issue we have in a timely and efficient manner is what CIDP needs. We felt accompanied during this transition period, something that we value.

Nusayha SokeechandManager-Biostatistics

Studies conducted with Datacapt

CIDP uses the Datacapt platform for conducting efficacy and tolerance cosmetic studies. The CRO also incorporates various instrumental tools such as C+K Devices (Cutometer, Corneometer, Sebumeter…)  in their study designs for efficacy claims substantiation.

Classified as ‘standard’ studies and with a volume of around 100 such studies yearly, it was beneficial for CIDP to consider the use of Datacapt solution for the efficient management of data generated during the conduct of these trials.

3 advantages in using Datacapt

User-friendly

The Datacapt solution is smooth and doesn’t require any specific skills. The tool is easy-to-use.

Fluidity

Being a cloud-based system Datacapt has a perfect network connection. Data backup is instantaneous.

Listening

The Datacapt Support Team has been easily reachable, always listening to our difficulties on our first steps on the platform. Datacapt is always trying to find solutions to our daily challenges.

Results thanks to Datacapt

Raising the bar on compliance

The regulations and norms with which Datacapt complies are a security belt. Compliance with international norms is a top priority as it certifies the security and integrity of the collected data. The fact that Datacapt complies with international regulations and guidelines such as HDS, 21 CFR PART 11, ICH GCP, and GDPR, gives a great level of confidence in the data, which is central to their quality promise.

A real improvement was felt on data collection and patient follow-up

The data is cleaner at the source. The time spent on data management activities, in particular, data entry and query management have reduced considerably. The management of daily logs and questionnaires is also easier.

Some tools have proven to be particularly useful

  • Monitoring and queries. Opening, resolving, and closing queries are very useful and easy. Indeed, having a direct overview of any query opened is much time-saving and allows for cleaner data.
  • Real-time access for Sponsors. With Datacapt, sponsors can be provided with special access to follow their projects’ progress in real-time. The fact that the special access can be selective, allowing the users to only access data that are relevant to them, is of added benefit. This in turn avoids forwarding multiple emails and spreadsheets to sponsors.

A change for the better for patients

The transition has been welcomed by many volunteers as using eConsent and ePRO modules have removed the burden of paper consent and made it easier to access the documents and process of signature. There are some hurdles to overcome within certain age groups who are not fully IT literate. To overcome this hurdle, CIDP proposes a hybrid mode of data collection and consenting.

In 3 words, Datacapt is?

Data-Friendly

User-Friendly

Compliance

To conclude

“Clinical trials deserve the highest level of integrity, and Datacapt can be the solution that gives this assurance, in a user-friendly and flexible manner. There is no reason not to switch from paper for efficacy/tolerance cosmetic studies.”

Antish KowlessurSenior Data Manager

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