What QA Validation documents will Clinical Studio provide?
The integrity of our customers’ study data is our greatest focus in our software development standards and practices. For that reason, we readily provide complete documentation on Clinical Studio’s data centers (locations, maintenance, backups, security, etc). At the customers’ request, we also provide our own vendor qualification checklist which verifies the processes, SOPs, and software practices we have in place. Due to the sensitive nature of information throughout Clinical Studio’s quality management system and functional specifications, we do not support audits which disclose our detailed internal documentation to third parties.
Why is Clinical Studio’s validation so simple?
Clinical Studio’s complete system is immediately available for users at no cost, free of commitment. Here’s how this concept is a game-changer for EDC QA validations, audits, RFIs, and other traditional processes:
Traditionally, study building and data capture systems have not been accessible until a contract was in place and valuable resources were dedicated. This creates an environment full of RFIs and lengthy audits to be performed prior to customers committing to a vendor for their studies. Most of those vendors also command such a significant price. In these cases, validations are well justified and should be performed diligently.
To follow suit of today’s technology business practices, Clinical Studio is non-contractual, based on month-to-month subscriptions which can be started, changed, and cancelled at any time. If our customers, after using the system, find they do not approve, it is incredibly simple to extract all study data, CRFs, audit trails, queries, and reports.
In the same way, we all use other software (i.e. email, word processing, spreadsheets, etc) to collect day-to-day data of all kinds. If we deem one of those systems to not meet our needs, we simply save our files, stop using it, and move to something else. Clinical Studio is the system, or platform, upon which users build their studies, and it will only perform to the level that a study is configured. Much like our Microsoft Excel spreadsheets are only as powerful as the user who configures the formulas, charts, and other features within. This is why Clinical Studio offers comprehensive training to its users. After being trained, Clinical Studio users are able to build compliant studies more powerful and efficient than they ever have before. In this way, validation has never been more accurate and resourceful.
While there are well thought-out FDA guidelines to follow, there are no enforced rules from regulatory bodies which strictly define validated systems. Consequently, we believe building a test study database, entering data, and using the tools freely available is the only way to accurately validate any system and prove its reliability. This is why we allow anyone to use the entire system at no cost. Moreover, we provide free training and account executives to make sure you completely understand how to use Clinical Studio in a compliant environment.
How to obtain the documents you need:
After learning about and using Clinical Studio, if you have any concerns or questions about the system’s QA processes, your Account Manager will work closely with you to ensure you have appropriate validation for your organization. This includes any disclosable documents to backup quality management and data center integrity. Due to the sensitive nature of internal documentation, Crucial Data Solutions does not participate in audits. Consequently, training is freely available for users to self-validate the system at no cost.