There’s a clear trend in the life sciences industry toward outsourcing clinical trial management to clinical research organizations (CROs). If you decide to join the movement, how should you go about getting data from your CROs into your clinical trial management system (CTMS)?
The most common method is to collect reports from CROs in the form of PDF or Excel documents, and then have an in-house resource key in the data. The drawbacks here include a slow, error-prone process that results in you as the Sponsor never having current data in your CTMS.
This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.
Another method is to give user accounts to CRO employees so that they can perform direct data entry. While this method can shorten the data entry timeline a little, it is still rather slow and error-prone, and it also brings with it security concerns, extra license fees, and the headaches that come with frequent personnel changes at CROs.
By far, the best method that I’ve seen pharma and medical device companies use to collect CTMS data from CROs is a specific kind of automated data integration: an XML-based “gateway” built into the Sponsor’s CTMS. In this approach, the Sponsor builds the gateway just once, and then each CRO they choose to partner with is required to meet the Sponsor’s specifications as part of the contract.
While integration does require a bigger up-front investment than other methods, if CROs are part of your strategy for the foreseeable future, it will pay for itself time and again.
Off the top of my head, here are some reasons why automated data integration is the best method of retrieving CTMS data from a CRO:
- Saves significant time on medial tasks, like data entry, data conversions, and data cleanup.
- Automatically checks for errors and creates error logs when they’re found.
- Ensures higher data quality across all integrated CROs.
- Provides clean data to the Sponsor as quickly as desired.
- It’s scalable – no need to train CRO personnel on using your CTMS, so CRO resources can scale up, scale down, or change as needed without impacting the data sharing process.
- Can be used with any CRO capable of outputting the data in the required format.
On October 7, 2014, Perficient will be hosting a webinar that will that will feature a customer case study around the automatic retrieval and loading of data in XML format via a custom utility and integration, which enables them to have an accurate snapshot of all their studies at any given time. To register, please click here. You can also click here to learn about our CTMS integration services.