Public safety is critically important when it comes to cell or gene therapy solutions. That’s why the FDA mandates clinical trials for all cell and gene therapy innovations before they can go to market.
For life sciences businesses focused on cell or gene therapy, these clinical trials are business-defining. They also can be complex to manage properly.
By leveraging an enterprise resource planning solution (ERP), however, cell and gene therapy companies can greatly simplify the process. The use of ERP for clinical trials also helps cell and gene therapy companies lay the foundation for commercialization after a successful clinical trial.
Where ERP Helps with Clinical Trials
There are chiefly five areas where an ERP helps with the clinical trial process. Each of these benefits can be achieved with homegrown or standalone solutions, but cell and gene therapy companies are much better served by using a single ERP system that encompasses all the needs of clinical trial management.
Document Management
Releases, consent forms, solution information, disclaimers, and process documentation result in large volumes of documents for a life sciences firm to manage during clinical trials.
With an ERP solution in place, cell and gene therapy companies can centralize and effectively manage all these documents that are necessary for the clinical trial process.
Everything related to the clinical trial can be stored and easily retrieved in a centralized, cloud-based ERP system. Distribution of materials can be timestamped automatically, restricted to eligible participants or clinicians, and easily accessed from any device with an internet connection.
Serial Batch Tracking
Fundamental to cell and gene therapy clinical trials is tracking each batch and dose of a solution under trial. This requires serialization.
ERP is built for this level of tracking and serialization, whether it is for a gene therapy clinical trial or the less critical requirements of tracking inventory at an automobile manufacturer. With ERP, a life sciences business can serialize and fully track each dose produced and administered as part of a clinical trial.
Life sciences firms undergoing a clinical trial can see the full scope of production and administration of cell or gene therapy tests at a glance, and sort these by type, dosage, batch or any other criteria needed for the trial.
Process Verification
Because an ERP system serializes and tracks each interaction during a clinical trial, it serves as a powerful tool for validating the results of a cell or gene therapy trial.
Life sciences businesses conducting a clinical trial can easily collect and prove the process and results from each step in a clinical trial because each step, interaction and result in the trial is logged within the system. This both makes clinical trial management easier, and it results in a clear audit trail that can be used for proving the results and verifying the trial was conducted properly.
Trial Project Management
Coordinating the various steps, people and resources for a clinical trial can be a significant task. While spreadsheets might work during basic research in the lab, cell and gene therapy companies will need something stronger for efficient clinical trials. Project management software is a must.
ERP comes with robust project management built-in. With the project management functionality built into ERP, life sciences firms can reduce the stress and complexity of clinical trial management. Gantt charts, timelines, task delegation, event triggers and alarms, and pre-defined workflows can help cell and gene therapy companies take the stress out of clinical trials.
Contact Management
The typical clinical trial involves lots of stakeholders, from participants to clinicians to the clinical trial management team. Keeping track of every person involved in a clinical trial and recording interactions requires robust contact management.
ERP comes with customer relationship management (CRM) functionality built-in, so cell and gene therapy companies can accurately and efficiently manage all these stakeholders and people interactions. Since the CRM built into ERP is built for sales teams, marketing departments and internal company management, it can make short work of keeping track of all the people details related to clinical trials.
Learn more about how ERP can help Cell and Gene Therapy Companies
ERP helps with clinical trials, but it also does a lot more for life sciences businesses; it is the foundation for taking cell and gene therapy solutions to market.
One of the advantages of ERP is that life sciences businesses can use the system for clinical trials or financial management during the early stages of company growth, then take advantage of additional functionality later on. Functionality can be turned on or off as needed, so life sciences businesses can use only what is needed while also laying the foundation for future growth.
Learn more about how ERP can help by watching our video on how ERP benefits life sciences business such as cell and gene therapy companies: ERP for Life Sciences Businesses.
For more on how ERP can help, you also can contact one of our experienced ERP consultants at (801) 642-0123 or by writing us at info@nbs-us.com.
