Company Category: Computer Software
Building a future proof businessDetails
Nubilaria Srl is an Information Technology company founded in 1999. Our company has its origins in the design, management and distribution of complex database systems and innovative IT services under strict international security policies.
A group of qualified and experienced professionals are the fundamentals of our success. They are the beating heart and the creative spirit of our company. Together we are constantly looking for innovative solutions.
Nubilaria’s Clinical business unit started operating in 2009 and has since been praised by many pharmaceutical industry leaders for the quality of its services. The Clinical Data Management services provided by the company support the entire data lifecycle.
EDC and Clinical Data Management Software
Our eClinical platform is suitable for any type of clinical study, for both human health care and animal health care, within a secure and validated environment.
ACTide EDC bundles-up with ACTide eCRF, our intuitive user interface, and ACTide Designer our eCRF configurator: The all-in-one solution.
We offer ACTide in two different configurations to accommodate your requirements.
Self-provisioning: for independent users who need a cutting-edge service to support fast & accurate prototype turn arounds
Full-service: for users who need to rely on our expertise to develop their eClinical solution without limits in complexity or scale.
Whatever configuration you choose, we are always available to support you and we go the extra-mile to ensure the success of your study.
ACTide benefits for CROs and Clinical Centres
Some of the features ACTide’s users (CROs and Clinical Centres) appreciate most are the quick and easy eCRF setup, the significant cost reductions, the monthly subscription fees, the non-profit/orphan diseases special pricing, a peace of mind on software compliance, easy auditing, study level validation tools and the native multilingual interface for multi-national trials.
eCRF, Clinical Data Management Solution and ePRO
ACTide eCRF is our intuitive user interface capable of delivering high productivity performances, which was developed keeping the end user in mind. ACTide eCRF is available as Software as a Service (SaaS) and is compatible with all web browsers and any device type.
ACTide eCRF provides your study team and site investigators with all the required tools to be successful in their daily tasks, including:
- Online randomization (IWRS)
- Multi-laboratory normal ranges set up and management
- AE and SAE management
- SAE safety database
- Drug Management
- Double Data Entry and reconciliation
- Monitoring tools eQuery management
- Query Builder for information retrieval
- KPI Dashboard
ACTide Designer is our powerful application to design, deploy and re-use eCRFs and their requirements, including:
- Metadata definitions
- Visits, Sections, Entry-points
- Multi-purpose edit-checks: mandatory, visibility, consistency, warning
- Annotated CRF, study level validation templates
It’s top-down approach dramatically reduces time-to-delivery as well as study test and validation phases. Our user-friendly interface minimizes your learning curve, making you instantly productive.
ACTide Designer can also be used to:
- Train your junior staff using an intuitive and easy-to-use interface.
- Build and share CRF template libraries between project management teams and clinical operations.
Clinical Data Management
- Real-time reports.
- Data export to Excel, SAS, SPSS.
Patient Reported Outcomes
Centralize and automate the collection and management of your Patient Reported Outcome (ePRO) data. Benefit from ACTide Designer’s expertise to create patient diaries in minutes.
- Native ePRO integration including email & SMS reminders.
- Support for photo upload and phone-native functions.
ACTide Medical Coding interface allows the reconciliation and normalisation of drug names and diseases terms submitted by investigators. ACTide Medical Coding is provided either as an integrated and profiled interface in each ACTide eCRF instance or as a stand-alone interface available in real-time during the data entry phase, as well as after DB-lock.
Integration with WHODrugs, MedDRA, other In-line and off-line coding services.
Randomization and Trial Supply Management
- Randomization and advanced allocation.
- Drug supply management and logistics with inventory control.
- Live and backup EU hosted servers.
- Encrypted communication.
ACTide comes with One2One total support and includes eLearning with an online documentation and certification program.
Our support team consists of qualified professionals with broad experience in developing eCRFs of any complexity and scale. It includes:
- Project Managers
- Clinical Data Managers
- Quality Assurance Managers
eCRF Compliance & Security
ACTide eCRF is fully validated, in compliance with:
- US FDA – 21 CFR Part 11
- EU GMP Annex 11
- GCP – Guideline for Good Clinical Practice
- ISO 9001:2015
- ISO/IEC 27001:2013
- GDPR Compliant
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