Services

We offer you fast, flexible and focused services ranging from ‘full service’ to ‘do-it-yourself’.

Select the services you require and create the ideal mix of professional study setup, consulting, data science and training services to meet your specific needs.

CLINICAL TRIAL SERVICES

eCRF Setup

Our experts will take care of your complicated electronic data collection forms, design branching questions, and develop in-form and cross-form validations and edit checks to maximize data cleaning at the field level. Our product also offers a library of forms in various therapeutic areas which are CDASH and CDISC compliant as per industry standards. We also provide configuration support for multi-lingual eCRF forms, and any localization support needed to configure the application workflow to align with the site’s local processes.

eTMF Setup

eTMF experts are available to help with establishing best practices and SOPs, governance, gap analysis, audit and inspection preparation, and much more. Supplement your internal expertise with additional consulting and/or stewardship

PV Management

EvidentIQ can take care of all of your Clinical Trial Safety requirements, including forming a data safety monitoring board. Once your company holds a marketing authorisation, regulatory requirements change. We can take care of all of your Pharmacovigilance services requirements for case processing, expedited reporting, periodic safety update reports (PSURs), literature screening and safety signal detection and review – in fact we can provide and run whichever pharmacovigilance services your operation requires.

Data Management

EvidentIQ offers Clinical Data Management services. We can support your study with full Data Management, from writing Data Management sections of your Clinical Study Protocol to clean file and database lock. Through established collaboration with partners, we can also tailor solutions with yet additional services for your study, up to a full service CRO solution.

Submission and Data Mapping

EvidentIQ supports conversion of both ongoing and legacy data to sponsor-specific standards in compliance with CDISC standards for clinical trials. Starting with data collection using CDASH to submission using SDTM and analysis using ADaM, access any level of assistance for your clinical data conversion and standardization needs.

eTechnology Strategy

EvidentIQ helps its customers make the right decisions by taking a critical look at the current state and understanding where and how the organization should change. Technology is the enabler of good processes. Be sure your organization is ready to drive the right automation rather than the automation driving you.

Protocol Development

EvidentIQ can provide complete protocol development services and draws on years of experience in designing and conducting clinical trials to produce a quality protocol that meets study objectives and all relevant regulatory requirements. We will work from our templates or your preferred format to create a protocol that has been thoroughly vetted by all relevant departments, with attention paid to every detail from execution at the site level through statistical considerations and everything in between.

Managed Service Model for MDR (Metadata Repository)

EvidentIQ provides a range of Managed Services for OpenStudyBuilder that can help pharmaceutical companies streamline their metadata management process. As specialists in CDISC standards since 2003, we offer comprehensive consulting services for all issues related to the OpenStudyBuilder. These services include Migration, Consulting, and Customization.

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DATA SCIENCE SERVICES

Observational Studies

EvidentIQ offers best-in-class RWE methodologies for observational patient studies/NIS with self-patient reported data in multiple diseases and geographical areas thanks to a direct access to a global patient platform – 500,000+ patients, 1,200+ chronic diseases. Our patient studies focus on treatment preference, quality of life, value of health, disease/treatment burden, unmet needs…using sophisticated methodologies (e-PROs, e-diaries, DCE…). We generate unique RWD/RWE to significantly help our life sciences customers support the value story of their product for HTA submission, pricing and reimbursement as well as their scientific communication with the clinical community.

Primary Market Research

Over the past years, patient centricity became a must-have for the life sciences industry. Thanks to quick and direct access to generate real-world patient insights, we help our pharma, medtech, biotech and academic partners to better understand patients’ needs at each phase of the drug/medical device lifecycle. Our patient surveys focus on patient pathway, customer understanding, disease/treatment burden, acceptability of treatment services/information needs and test of concepts for patient solutions. Our solutions propose online quantitative surveys, test of concepts and quick surveys via PatientLive platform.

IRB and EC Management

All our RWE projects are backed by a strong regulatory expertise at international level. Depending on the methodology of the research and objectives of the observational study, we will support you to manage IRB submission in the US and local EC submission in Europe and other regions. Our data scientist team will develop all required material to complete the submission: Protocol Writing, Statistical Analysis Plan (SAP), Data Management Plan (DMP), Information Consent Form (ICF) and other patient study materials.

PV and GDPR Compliance

EvidentIQ offers high-level standards and services in terms of Pharmacovigilance and GDPR (General Data Prorection Regulation) compliance. We ensure that all our projets fulfill all regulatory requirements in terms of AE reporting and GDPR. Our project teams are trained and certified on our client’s Pharmacovigilance process at the beginning of each project. For any research project, eConsent is collected from patient prior to starting the study with an information notice associated. Also, consent is collected at subscription on Carenity. All patient data is confidential and is shared in aggregated form, for GDPR compliance.

Scientific Communications

HTAs, KOLs, and the pharma industry acknowledge our real-world patient data can improve patients’ outcomes. Scientific communication is key to value the results of real-world patient studies in order to support the value story of your products or share evidence with the clinical community. EvidentIQ helps you to publish the results of our real-world patient studies through abstract/poster at scientific congress and manuscript in a peer reviewed-journal. Our team of data scientists will bring our expertise to support you from medical writing to management of submission. We have conducted 100+ scientific publications based on real-world patient insights.

Digital Communication

We use a wide range of channels to ensure proper communication of your message to our audience. With our Digital Communication service we can offer you sponsored newsletters, online banners on Carenity, Facebook posts, video interview and expert content, motion design videos and infographics.

Data Linkage

Data Linkage is a method that helps match and merge records from different sources to get a richer dataset and more valuable evidence. EvidentIQ uses significant clinical data expertise, data science analysis, and access to Carenity patient platform, to successfully conduct state of the art data linkage studies. Our innovative data linkage capabilities combine unique self-patient reported data with biomarkers collected by a wearable/sensor through continuous monitoring, bringing RWE to the next level.

24/7 SOFTWARE SUPPORT

The products in our portfolio are web-based and are provided using a Customer Subscription Service model.

We offer solutions both in the private and public cloud. Depending on your requirements, hosting of our cloud services can take place on the respective continent (Europe or US).

We have extensive automated monitoring procedures in place. This in combination with the 24/7 availability of our technicians and the regularly tested Business Continuity procedures, guarantees maximum availability of our solutions.

For all our products, you can reach us for service requests or professional support (24/7) via our Hotline, via e-mail or via our Support Portal.

GENERAL SERVICES

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Hardware Provisioning

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Vulnerability Management

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System Monitoring

CUSTOMER SUCCESS

EvidentIQ offers fast, flexible and focused services ranging from ‘full service’ to ‘do-it-yourself’. Select the services you require and create the ideal mix of professional study setup, consulting and training services to meet your specific needs. Our Customer Success team can be responsible for all or just a subset of the points listed below, as required.

eCRF build
Configuration of Edit Checks/Queries
Creation of user roles and access rights
Creation of (customized) online reports and data exports
Configuration of specific modules such as Randomization, Drug Management and Logistics
Configuration of laboratory data import