Most of the companies are spending a significant amount of cost and manpower to manage clinical trial activities as database building, monitoring and management of data using a variety of EDC systems as Inform, Rave, Oracle Clinical Remote Data Capture, Veracity, etc.

Many software, web-based applications, and cloud source management tools are being used in various stages of clinical development, here are some of them

  • Softwares in protocol design
  • Site selection and startup platforms
  • Several apps in patient recruitment
  • Trial administration
    • Operational Data Management
    • Managements systems in Drug and Supply Logistics
    • Patient management
    • Digital biomarkers identifiers
    • Virtual trials 

Let’s discuss various steps in conducting clinical trials and some of the useful tools that greatly help small, medium and large scale organizations in drug development.

The software in protocol designs

Protocol design is a critical step before initiating a clinical trial. An efficient protocol minimizes delays arisen due to amendments, which in turn reduce the costs incurred due to delays and help in completing the trials faster. According to a report 1 in 3, FDA drug approvals have safety issues after coming to market and these can be minimized with proper protocols.

Many organizations have specialties in designing protocols, however for those companies where they lack specialization, Transparency Life Sciences and VitalCrowd are building platforms that crowdsource protocols for clinical trials.

  • Verified Clinical Trials (VCT) and TriNetX have some real-time tools to analyze protocols.
  • Along with these organization, there are non-profit organizations which are working to help in designing, for example, Clinical Trials Transformation Initiative (CTTI), which provide guidelines for use of mobile technology in clinical trials with a focus on novel endpoint design. 

Site identification and selection

Site identification is very crucial for any clinical trial as it drives the fate of the drug further. Improper site identification, inefficient clinical investigators lead to failures in patient recruitment, patient retainment, and generation of quality data. Various platforms have been developed to help sponsor or clinical research organization to identify potential sites and qualified clinical investigators.

Credevo has developed a web-based platform where the trial manager or sponsor can conduct feasibility with clinical investigators and sites all around the world for any therapeutic area. 

Conducting feasibility is super easy on Credevo, just requires signing up & post a few details of the project, that’s it, you reach thousands of clinical investigators and sites all over the world. Prepare Feasibility Questionnaire for the information you are looking for. Based on the clinical investigator profile, FQ responses of the clinical investigators review and finalize the sites.


Learn more about conducting clinical trial feasibility


Patient management

Most about 70% of clinical trials fail due to poor patient recruitment and retention. Identifying and recruiting 100% of patients for studies is a nightmare for many clinical studies and often with rare disease clinical trials. Many management tools have been developed by many organizations that use various techniques for resolving this burden such as patient recruiting platforms, 

PatientsLikeMe, TrialSpark, TrialX, SubjectWell, StudyKIK, Seeker Health, mProve Health, Langland, Clinical Connection, Comprehend Clinically, and FindMeCure is some of them.

Trial conduction

Once the trials have been started, data management comes another challenging task for conducting clinical trials 

Data management

Clinical Data management in clinical research helps in the process of data compilation and organizes clinical data in compliance with good clinical data management practices and applicable regulatory requirements. Using efficient technology-enabled methods to manage clinical details can enhance the speed with which the drug is developed and commercialized,

The fundamental objective to use the Clinical Data Management (CDM) process is to provide high-quality data by reducing data entry errors and avoid negligible data as far as possible and gather maximum relevant data for analysis. The efficient use of data-capture tools may make sure that high-quality details are available for early review and fast decision-making. 

Companies spend huge amounts in conducting clinical trials to generate quality data in order to obtain regulatory approvals. The data efficiency increases with minimal or no errors, unflawed data entry and comprehensive.

To achieve this objective, there are several tools available for clinical data management in clinical research and these are popularly called Clinical Data Management Systems (CDMS). The use of Electronic Data-Capturing (EDC) technology and effective data cleaning methods and Discrete Data Management plans (DMP) has started transforming the activities of clinical research operations for sponsors, contract research organizations and sites.

Best clinical data management practices are adopted in clinical research to make sure that the data is comprehensive, consistent, and thoroughly checked. This can be achieved by using 21 CFR 11 compliance software tools that keep up an audit trail and offer easy detection and resolution of discrepancies if any.

CDMS is of essentiality of great importance in handling large amounts of data generated simultaneously from different sites distributed across several continents in multi-centered clinical trials.

Clinical Trial Management System – CTMS

A Clinical Trial Management System (CTMS) is a software system used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research. This system is used to maintain and manage the planning, performing and reporting functions, along with participant or subject contact information, tracking deadlines and milestones.

Electronic Data Capture (EDC)

It’s difficult to capture data that is generated during a clinical trial. To overcome this a computerized system was designed to collect data during clinical trials in an electronic format, and the system is called EDC – Electronic Data Capture or EDC. This system is used by most pharmaceuticals and CROs these days.

There are basically three components on an EDC – Graphical User Interface, 

  • The first being the Graphical User Interface. The contains data entry screens that have a set of data fields in to which the data is entered
  • Next comes the Validation Component to check the user data for any obvious errors, and 
  • The third and final one is the Reporting Tool for data analysis.

Oracle Clinical, Medidata Rave and Inform by Phase Forward are some of the popular used EDC Systems.

Due to many online systems available, a comparison app has been developed. For example GetApp, this app allows to make an easy online Clinical Trial Management software comparison in just a few minutes by filtering by deployment method (such as Web-based, Cloud Computing or Client-Server), operating system (including Mac, Windows, Linux, iOS, Android), pricing (including Free and Subscription), platform (including Google Apps, Salesforce, Intuit, NetSuite, SAP) and supported location.

Advantages of EDC system 

  • The first and foremost important being error minimization EDC systems, allow user-friendly and systematic approach tend to minimize these errors to a minimum,
  • Need for multiple copies of data for submission to regulatory authorities which may take long time and delay thus ensuring a faster mode of submission to the regulatory authorities 
  • Helps in monitoring the progress of the trial in a smooth way and can make sure that there were no deviations from the protocol during the conduct of the study
  • Data review is easier on such systems while reviewing papers previously was tiresome.
  • EDC saves up a huge space and avoids unnecessary use of paperwork and intern environment friendly.
  • The data generated in wide geography makes it challenging to handle the data. Utilizing the EDC system accelerates and makes data management easy and flexible.
  • EDC system offers web-based data entry, medical monitoring, data review, and data clarification processes through a cost-effective process.
  • The forms can be stored in the library available in the EDC system and these forms can be copied from the library and utilized for future trials. 

From small to large pharmaceutical & contract research organizations have begun using the EDC system as a data management tool for clinical research. 

Disadvantages 

Along with advantages, there are disadvantages such as this sophisticated management systems require special technical staff. CDM process demands a broad range of skills such as scientific, technical, IT, systems engineering, project management, and interpersonal skills to handle, drive and offer esteemed services in managing clinical data in this e-clinical era.

Management system in supply logistics

Previously it was thought that supply logistics systems do not require high technical systems, but it’s now not the case where electronic data capture systems utilized in clinical trials are automated to logistics workflows.

There are many logistics supply organizations that not only supply clinical trial materials but also electronics that are used to capture the patient data. Clinical supply management is critical in rare disease clinical trials as the requirements are often not predictable.

Credevo provides logistic solutions in clinical trials and special logistics services in rare disease clinical trials. Contact us at helpdesk@credevo.com or fill the contact form below 


Learn more about clinical trial shipment in rare diseases


Digital biomarkers

Digital biomarkers are tools that collect behavioral and physiological data. These tools can be used to diagnose and to treat patients remotely.

The FDA has recently made a number of forward-thinking changes that will speed up the development of digital biomarkers. The FDA’s Center for Devices and Radiological Health has spun out a software group headed by Bakul Patel to look at more at these digital tools and also released new guidelines for Software as Medical Device (SaMD)

Virtual trials

Virtual sites are the trending leap for pharma companies and CROs as these trials are cheaper, accessing a wider population and more opportunities to capture real-world data from participants. And this is more prominent in rare disease clinical trials where the patients are often scattered and traveling becomes a huge hurdle for patients and financial burdens for sponsors.

Patient retention is a huge concern for rare disease clinical trials and virtual trials can sort this issue and help in the timely completion of clinical trials.

However, these virtual trials are not applicable to types of clinical trials where patients need to visit the research site for taking treatment. For example, cancer patients who are on chemo. 

There are some companies working for this type of approach such as SageBionetworks (a non-profit organization)

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References

  1. https://www.jli.edu.in/blog/electronic-data-capture-edc-in-clinical-trials/?gclid=EAIaIQobChMI94eO2sC16AIVkA4rCh2iDgApEAMYASAAEgIcxPD_BwE
  2. https://www.jli.edu.in/blog/electronic-data-capture-edc-systems-in-clinical-trials/
  3. https://www.jli.edu.in/blog/what-is-clinical-data-management/
  4. https://blog.andreacoravos.com/software-enabled-clinical-trials-8da53f4cd271