The eClinical trial technologies market is set to reach $1.37 billion USD by 2018. The driving forces behind this surge are the pharma industry’s narrowing drug pipelines, expiring patents of popular drugs and the scarcity of prospective drug launches. Therefore, there is a need in the pharma industry to find tools that can accelerate the drug development process and boost productivity. ARITHMOS explores how IT tools are influencing operational strategies in the pharma industry.
Why are pharma companies looking to implement life science technologies? Clinical trial technologies enable real-time data analysis, cut costs while optimizing the drug development process and are utilized to make “go/no-go” decisions quicker. However, there are different needs for different market sectors such as large pharma, small to mid-size pharma (SMB), biotechs, academic and hospital research centers and CROs.
Let’s look at the similarities and differences for large pharma vs. SMB pharma; IT needs include:
- Compliance with Regulations: adapting a risk based approach, shortening the validation effort
- Costs: low cost/open source solutions, effective project management
- Technology Solutions: support for technology selection, technical support and maintenance, external hosting solutions
- Flexibility: Customization, easy-to-use clinical applications, integration with other systems/devices
- Efficient Processes: solutions to streamline internal processes
The SMB market sector, however, faces challenges in implementing IT solutions. They often have a lack of expertise, training and finances for technology upgrades which leads to limited adoption of IT solutions. SMB, compared to large pharma, does not have economies of scale to exploit the building of informatics system solutions.
In addition, SMB companies are affected by the risks of various failure scenarios such as: creating a system they can’t afford to validate, creating a system that is unable to grow with the company, or creating a system that is too costly to maintain.
All of these factors influence how a company integrates IT into an operating strategy. The solution is to engage the support of an IT supplier which can provide:
- Business Requirement Analysis
- Selection of appropriate eClinical Solutions
- Consultancy for the implementation, validation, support and maintenance of the chosen solution
- Hosting model/SaaS
- Integration with other applications (ePRO/EDC integration)
- Providing customized reporting
- End User Training (e.g. eLearning)
Let’s look at an example of this strategy put into practice. Generally, researchers don’t want to spend much time finding data management solutions or solving technology support problems. They would rather spend their time doing research.
Therefore the high level EDC business requirements would be defined as: low-cost, web-based, ease of designing CRFs including automated error detection, scalable and the availability of training materials and documentation.
Pharma companies, especially those in SMB category, can implement a customized EDC application. ARITHMOS has a proprietary EDC system called Symphony which works under the SaaS (software as a service) model. It is an intuitive EDC platform ideal for Investigator’s basic needs and provides customized reporting tools using SAS programming. HelpDesk is available 24/7 via an online ticketing platform or a toll free number for Investigator technical support.
A customizable life science technology solution is appropriate in this situation because the Sponsor is paying for the functionalities needed and not paying for those not applicable to the study. The Sponsor and site personnel can use the same application for different projects and reuse the application with slight modifications. Therefore, training efforts are kept to a minimum due to high usability.
Are study goals reached?
This customized EDC solution allows for published study results with a high impact factor. The study data is reliable and available in real-time. Finally, there is a reduced effort in technology on the part of Investigators and site personnel allowing them to increase time spent in clinical research activities.
For more information on customizable IT solutions or to consult with ARITHMOS on implementing IT into your clinical trial strategy, contact us at email@example.com.