As a data-focused CRO, Quanticate has formed partnerships with a number of key vendors to offer customers a flexible solution based around our QuantiCliQ portal which enables easy access to data across studies using a centralized visual approach. These technologies enable data capture (EDC, e-PRO, IVRS and Pen / Pad technologies), analysis and effective reporting. Our team has experience supporting many leading and niche technologies:
Quanticate has formed a partnership with Comprehend Clinical to provide access to pooled cross-study data, various analysis and reporting through visualization. Our QuantiCliQ portal provides real-time and flexible access to clinical data in addition to various project management and communication tools. Our team can provide a demonstration of the QuantiCliQ portal. Please contact us for additional information.
Electronic Data Capture (EDC) Solutions
Quanticate is able to support and build a wide range of electronic data capture (EDC) solutions. We can provide feedback on the different technologies and offer suggested solutions according to trial phase and designs. We have experience supporting Medidata (RAVE), Oracle Clinical (INFORM & OC-RDC), Open Clinica and a number of other EDC systems. Please contact us with your requirements and objectives and we would be happy to provide advice.
Quanticate can offer pen-based approaches to capturing onsite data. We are working with a number of providers including Escript and Kayentis. Contact us to find out more about the advantages and disadvantages of this approach.
It is important for us to constantly evaluate our customer requirements and available technologies. With the advent of pad-technology and the future requirement of electronic health records, we have formed relationships with a number of forward-thinking companies. As such, we can provide pad-based solutions from companies such as Clinical Ink and Kayentis. Please contact us to discuss whether this type of approach would be appropriate for your development program or study.
Quanticate can provide each client with a specific, secure safety database configured to specific requirements. Quanticate’s in-house safety database is Oracle Argus, a leading, industry-standard, validated safety database, which is fully 21CFR part 11 and ICH E2B compliant.
In addition our team of specialists have experience working with many leading safety databases including ARISg, Empirica Trace and Oracle AERs. The team can provide efficient support through access to a clients existing safety database.
Our pharmacovigilance specialists are Eudravigilance and XEVMPD certified, enabling Quanticate to perform all product entries onto the Eudravigilance Medicinal Product Database and to conduct electronic reporting of Individual Case Safety Reports (ICSRs) via EVWEB to EMA and National Competent Authorities on behalf of a client.
Thank you very much for the document with the sample size calculations and especially for your additional thoughts on design aspects. This is very helpful and very much appreciated!
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