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When you initiate a new study, whether it is a device or a drug study, at some point you must deal with a critical decision: which company will build the electronic CRF for us? Who will be in charge of creating the database/ EDC for our precious data?
So here are some interesting points to consider:
Is the company a professional data management company?
Or an EDC software company that also offers EDC building services? Or a company that employs students/ people who are not professional clinical data managers?
This is of highest importance: an EDC software company is specialized in developing electronic tools for your needs, but what about thoroughly reading a protocol, detecting the critical data points? Noticing that the CRF does not include some requirements from the protocol? That the CRF as it is does not collect all the data points that are required for the analysis of the study endpoints ? What about building the EDC according to the regulatory requirements?
At ClinXL, we always perform a first protocol/CRF review and our clients are so grateful that we note many crucial discrepancies between the protocol and the CRF, or that we suggest adding specific forms/ fields, a visit planner, more auto-checks (warnings), and auto-calculated fields wherever possible, in order to increase compliance with the protocol and maximize the trial success. We have real Clinical Data Management skills with more than 20 years experience. That's why ClinXL is not only an "EDC builder" company but an EDC success company.
Is the company developing EDCs according to regulatory requirements?
Do they use CDISC/SDTM variable nomenclature? How do they ensure the patient's anonymization? How do they deal with double blind randomization? Do they know the differences between European / USA regulatory requirements ? How data is imported/ exported?
Will the EDC provider accompany you all along until the study closure?
Some companies just "make the job" and deliver the EDC that they built according to the paper CRF you provided. This is what we call "EDC builder robots". You are not involved in the EDC building process, you just get your EDC at the end without giving your first impressions during the EDC building: how you would like the EDC design to be, or how you would want the forms to look like, or maybe fields that should be added, or maybe a form that should be hidden until another one is completed, or an email notification to set up when a specific event occurs in the EDC... Then, you get a standard user guidelines document - the same one that all clients will receive- and here we go for the study!! If you have a specific question or requirement during the study conduct, you will contact the EDC support team: will they be responsive? will they know your specific study? Or is the support team a global one with answers on technical issues only but unable to answer questions about the study requirements according to the protocol? Do they speak your language? At ClinXL, you (sponsor, investigator, CRA) are involved from the very first stage of the EDC building, you give your feedback and we readjust everything until your entire satisfaction. We provide a study-specific user guidelines, with precise instructions on when and how to enter data, how to schedule visits properly, how to monitor, and how to be fully compliant with the protocol. When you have technical or functional issues, we are here for you and can answer your questions in 4 languages. Our help desk is here, not on the other side of the world. As we know all the details from the protocol, we provide a study-specific help desk. That makes a huge difference!