Decentralized clinical trials have been circulating around for some time now being addressed as virtual, remote, at-home, or siteless clinical trials. Whatever the name, the goals remain the same: easing the trial process with reduction/ partial elimination of travel requirements to sites. 

The recent proliferation of decentralized clinical trials (DCT) amongst businesses, in haste to cope with the pandemic, ultimately turned out to be a boon. It eventually positioned itself as a manner of culminating technological advancements and novel solutions to create a hybrid approach apt for diverse and geographically dispersed volunteers.

The approach has shown significant results in reduced patient drop-out rates, reduction in study costs, real-time patient data capture, and most importantly positively influencing faster-to-market of several drugs. 

According to studies, conventional clinical trials face several challenges related to geography, health, and travel constraints.

However, being quiet on the early stage of its adoption lifecycle, DCT solutions face several challenges which are evidently new to the domain. It would not be wrong to mention that a holistic DCT solution would require an end-to-end understanding of these challenges with an embedded solution to evade or reduce the chances of errors.

Cloudbyz DCT solution offers end-to-end, cloud-based, SaaS features to cater to every virtual clinical trial requirement in the healthcare and life science industry.  Cloudbyz pioneers in providing digital capabilities and clinical trial management solutions (CTMS) across the clinical trials lifecycle with patient centricity at its core.  Our portfolio includes smart features for eConsent, eCRF, EDC, ePRO, remote monitoring, remote SDC, eCOA, eDiary, virtual Patient Recruitment, eTMF, among others.

Let us understand the complexities and challenges of the decentralized clinical trial and how the Cloudbyz DCT solution successfully caters to each one of them.

Top 10 clinical trial challenges resolved by Cloudbyz DCT solutions

1. Limited availability of cloud platforms 

The DCT landscape, at present, lacks innumerable availability for cloud-based platform vendors to choose from. This results in the selective availability of vendors with hardly any choice apart from being satisfied with their offerings.

Cloudbyz DCT solution offering:

Cloudbyz DCT solution is built on the renowned Salesforce CRM platform offering an additional layer of flexibility and scalability to its users. Our solution defines almost every requirement across all the phases of a clinical trial to support functions like virtual patient recruitment, patient monitoring, regulatory oversight, eConsent, etc.

2. Limited configurability feature of DCT solutions

Considering the colossal patient data generated on a daily basis via remote devices and patient applications streaming, the burden of data management is critical.

Cloudbyz DCT solution offering:

Cloudbyz DCT solution offers a configurable centralized platform solution that facilitates real-time extraction, collection, and automatic roll-up of data to specific study profiles. We also deliver performance metric solutions and analysis of data sets for easy trend analysis.  Apart from this, our portfolio also delivers document and database management for datasets to maximize trial efficiency. 

Read our in-house expert blog to understand the need for a centralized platform for clinical research studies.

3. Integration with other clinical systems is complex

Clinical trial sites are complex set-ups therefore maintaining a configurability quotient for easy integration is key for a suitable DCT solution.

Cloudbyz DCT solution offering:

Cloudbyz DCT enables multiple integrations with third-party applications and existing infrastructure, making itself an ideal choice for any enterprise. It also delivers easy integration with other clinical systems including Electronic Data Capture (EDC) systems, data repositories, analytics and reporting tools, etc. to provide a synchronized trial solution for increased virtual efficiency. 

Intrigued by our service offerings? Learn more specifically about our features. 

4. Complex studies require longer start-up times

It has been reported that clinical studies with increasing complexity require more than one platform for functioning. This results in prolonged data migrations, data translations, IRB approvals, device provisioning among others.  

Cloudbyz DCT solution offering:

Cloudbyz DCT solution facilitates data portability, data management, information translation, system integration, and a chatter-based collaboration forum for investigators and study coordinators. Our users also benefit from the Study library that serves as a repository for study-related training tools and documents. 

Take a look at our capabilities in the Study-Start-up. 

5. Translation complexities 

With the increasing preference and mandate for a diverse subject base, all important data/information and procedure needs to be free of language constraint. 

Cloudbyz DCT solution offering:

Cloudbyz DCT solution, a cloud-based, built-on salesforce solution offers 20+ language support for all its solutions. This facilitates an easy trial of information distribution amongst linguistically different site stakeholders and eventually breaks the communication barrier to a great extent.

Comparative analysis of conventional and DCT model of the clinical trial process

(Source: MDPI Report)

6. Lack of proper training to use the virtual solutions

Enterprises adopting the technologically upgraded DCT solution need the availability of a subject matter expert at the site to educate and train the end-users. The absence of which might completely diminish the agenda of remote monitoring/data extraction. On the other hand, DCT solution vendors also struggle with a high turnover rate and limited training and enablement resources.

Cloudbyz DCT solution offering:

Cloudbyz DCT solutions are easy to integrate, deploy and use. Our developers and employees are well versed with the required expertise and are HIPAA certified. We also ensure a proper training session for our end-users followed by an exchange of user manual and training materials to the enterprises. 

Anything specific on your mind? Speak to our subject matter expert. Schedule a call.

7. Existing vendors offer several levels of sophistication and quality

Being a highly lucrative marketplace, the need for a distinguished DCT offering is pushing DCT vendors to inculcate several sophisticated features to make their mark. Sponsors require proactiveness for a  certain level of direct vendor oversight and interaction to ensure success. 

Cloudbyz DCT solution offering:

Cloudbyz DCT solutions declare its uniqueness through their easy usability without compromising on industry benchmark features. Cloudbyz is an ISO/IEC 27001:2013 certified company. The certification receipt declares our adherence to stringent and systematic data security standards within the company, regarding confidentiality, integrity, and usage of customers’ information. Our product suite also offers real-time or at least near real-time tracking of investigational products and logistics to simplify the complexity of the existing logistics.

Cloudbyz Decentralized Clinical Trial Solution caters to every phase of the trial, benefitting both sponsors and CROs.

8. Paper-based processes complicate operations

Clinical trial companies have rapidly adopted the DCT model, however, several other trial activities remain attached to manual paper-based methodologies. This might be due to expensive integration requirements, constraints of configuration with existing infrastructure, or a psychological setback in digitalizing important documents with fear of cyber theft.

Cloudbyz DCT solution offering:

Cloudbyz DCT solution offers a complete cloud-based solution with the safety of the Salesforce shield. Our digital solutions like eConsent, eCOA, ePRO, eTMF, and others facilitate digitalization and cloud-based storage of all critical documents with easy access and centralized repository management. 

9. Increasing trial complexity require services from multiple vendors

The level of complexity of any clinical trial depends upon the sophistication of the to-be-produced drug and its compounds, the usability of the drug, and several other factors. Consequently, some studies require engaging multiple vendors to address requirements for seamless volume, therapeutic needs, site collaborations, etc. 

Cloudbyz DCT solution offering:

Cloudbyz understands that introducing multiple vendors into the existing operating model further complicates the process and its management. As a solution, we structured our DCT portfolio to deliver value to our user’s innumerable clinical trial requirements on a single platform. This positions us as a complete ‘one-stop-shop’ for all virtual CTMS solution aspirants.

10. Diversified remote patient engagement requirements

With several sites and patients to monitor in siteless patient management, the need for a person-to-person connection seems difficult. It might also create a gap between the physician and patient relationship due to reduced personal engagement. 

Cloudbyz DCT solution offering:

Cloudbyz DCT solutions offer several cloud-based centralized platforms like investigator portal/ patient portal and other technologically upgraded smart features. These features suffice every person-to-person engagement manners via a virtual ecosystem leaving patients and physicians equally content.

We also realized that the incorporation of augmented reality and virtual reality technology can amplify the patient’s engagement and interaction with the CROs/physicians and also help them improve their overall clinical trial experience. 

Holistically, Cloudbyz DCT solution can enable enterprises to accelerate their clinical trial process with digital cloud-based solutions to reduce data processing time, and improve study administration.