A number of solutions are being built to manage day-to-day clinical trial activities. Most solution providers in the market claim to have a complete CTMS solution, however, not all solutions have end-to-end features. A checklist for systematic assessment of the available CTMS solutions prior to investment is essential. Most importantly, CTMS will be used to manage sensitive medical data for clinical research and have to be able to meet the ever-changing and evolving regulatory requirements. Hence, security and flexibility of the solutions are the most critical considerations.
5 Point Checklist to Choose the Right CTMS
✓ Prioritize your Organization Needs:
It is highly important to figure out what kind of CTMS the organization needs. If the organization is a Coordinating Site center for clinical trials a CTMS with the best patient recruitment solutions might be the right choice. If the organization is a CRO or a Sponsor, a comprehensive end-to-end solution with inbuilt clinical trial financial management is the right choice.
✓ Compare the Features and Compliance Readiness:
There are more than 20 different vendors in the market offering CTMS solutions. It is important to do online research and review and compare the CTMS features. It is also important to ask the right questions.
- Is the CTMS solution 21 CFR 11 and HIPAA compliant?
- Is the product customizable to the organization’s clinical research business process?
- What integrated features the solution offers and how securely can data be migrated and managed?
- Does the CTMS have the capability for real-time tracking and event-driven actions like automatic generation of payments, document expiry notifications etc?
✓ Check Your Wallet:
The most important aspect is to decide how much the organization is ready to spend taking into account the Total Cost of Ownership (TCO). Different vendors price the products in various ways. It is important to check the prices on licenses as well as annual maintenance costs. A few vendors charge additional costs on data integrations, services and training. It is important to note the Capex and Opex impact of traditional On-premise solutions vs the Cloud solutions.
✓ Try it Yourself:
This is the best freebies the companies offer. Choosing the best-fit CTMS solution is analogous to the size of a dress in a showroom. Just as the size of a dress need not fit two individuals. It is important to do a trial of the solution to understand if the solution addresses the organization’s challenges.
✓ Develop Your Scorecard and buy the best One:
It is essential to develop a scorecard of the CTMS solutions to buy, as the vendors demonstrate their solutions. The scorecard can be developed on several metrics such as:
- Product differentiators such as ease-of-use and template driven features
- Meets audit and compliance requirements
- Adequate support services from the vendors
- Scalable and flexible for future growth and process changes
- ROI and TCO
Why Cloudbyz is the right CTMS solution?
Cloudbyz has developed a cloud-based CTMS solution built natively on the innovative Salesforce Cloud Platform to manage end-to-end clinical trial operations. Cloudbyz CTMS enables faster implementation and helps drive user adoption across clinical research with the following capabilities:
- Centralized One stop end-to-end solution – Cloudbyz CTMS enables users to manage all end-to-end clinical research activities starting from pre-planning of clinical studies, start-up, conduct to closeout in a single solution.
- Template Driven – Cloudbyz CTMS is template driven to easily manage the study specific variations and data-driven to drive workflow across clinical study process areas such as:
- Trip Report Templates – SQV, SIV, IMV, and COV forms are template driven with a list of predefined questions, checklists that can be set up based on study-specific or generic requirements.
- Feasibility Questionnaire – predefined template with questions which can be set up based on specific study
- Visit Plan – Predefined visit plan as per protocol to set up a visit and procedure schedule which can be used for automation of subject visit calendar and payment generation upon subject visits.
- Budget and Rate Card Templates – Predefined budget templates, rate cards at study and site level for standard tasks, visits and procedures can be set up based on which budgets can be created easily.
- eTMF Templates – Predefined DIA folder structure or custom study and site level folder structure can be created
- Essential Documentation checklists – Study level, site level and region level essential / greenlight documentation checklists
- Project Template – Predefined project templates to reuse to quickly create clinical projects on click of a button.
- Pre-screen templates – Ability to setup pre-screen questionnaire for patient screening on the telephone, web pre-screen and chatbots
- Real-time Reports and Dashboards – Cloudbyz CTMS comes with the ability to create new reports and dashboards with point-and-click and drag-and-drop capability with no dependency on technical skills. Cloudbyz CTMS comes with more than 200+ pre-built reports and dashboards based on industry best practices
- Real-time visibility and real-time tracking – Cloudbyz CTMS offers a 360-degree view and visibility in tracking the trial documents, procedures, and Adverse events. The solution also provides the ability to track shipments, automatic generation of payments and receipts.
- Security and compliance – Cloudbyz CTMS is built on a secure Salesforce.com platform and compliant with the regulatory guidelines such as 21 CFR, Annexure 11 (EU), HIPAA and PHI.
Why Cloudbyz chose Salesforce Platform?
Cloudbyz chose the Salesforce.com platform, which is a leading Platform as a Service (PaaS) and has been adopted by thousands of organizations and millions of end users globally for its ease of use, scalability, flexibility and security.
Salesforce is built on a multi-tenant infrastructure, which means that apps are run on a shared data center, lowering costs and reducing the need to devote specific resources (time, money, and people) for maintenance. The Platform comes with a continuous cycle of innovation bringing new capabilities like modern user interface (Lightning), state-of-art Artificial Intelligence features (Einstein AI), Blockchain, etc that can be leveraged by all applications like Cloudbyz CTMS and its users to be at the cutting edge of innovation.
“The recent decision by Salesforce to acquire Tableau, might further enhance the incorporation of advanced analytics and visualization capabilities into the CTMS in the future.”
Further queries or thoughts please comment or feel free to contact:
Srinivas Sashidhar K
Domain Specialist – Life Sciences
About the Author:
Srinivas Sashidhar is the Life Sciences Domain Specialist and Compliance Lead at Cloudbyz Inc. He has a decade of experience in strategic consulting working with leading pharmaceutical & life sciences companies. His expertise includes Pharmaceutical, Clinical Diagnostics, Medical Devices, Healthcare IT and Drug discovery tools markets.