Clinical Data Management | Medidata Solutions (2024)

Rave Data Management

Medidata’s Rave Data Management solutions for clinical data management and clinical data capture eliminate complex, manual processes and deliver higher quality data for faster insights. Resulting in critical reductions in study build time, query volume, data correction rates, and reporting turnaround.

Rave Data Management solutions, running on the Medidata Platform, deliver interoperability between Rave EDC, eCOA, eConsent, myMedidata, Sensor Cloud, RTSM, Imaging, Coder,Safety Gateway and Patient Data Surveillance.

“It is always helpful that we’re using multiple modules [from Medidata] and the interface between them is already there. I don’t have to worry about the backend APIs or interfaces between one system and another. It makes it just leaner and easier to use.”

– Salam Ammus, Executive Director, Clinical Data Management, Alkermes

“… Our partnership with Medidata has been very collaborative from a data management perspective… It’s made data management easier for reviewing the data, drawing out metrics, and building the forms. It’s an easier platform to design.”

– Cathy Hult, Director of Data Management, PROMETRIKA

“…the Medidata products are very innovative and support our very complex oncology studies…”

– Vijay Chundru,Senior Director, EDC Programming Team, Global Clinical Data Operations, Jazz Pharmaceuticals

See the Medidata Platform’s clinical data capture and management capabilities in action. Includes eConsent, eCOA, RTSM, Sensors, Imaging, and capture of EHR data; and Patient Data Surveillance with no code, drag and drop listings, and automatic generation/posting of multiple queries to enable comprehensive, aggregated data review.

Your Path to Next- Generation Clinical Data Management

Clinical Data Management | Medidata Solutions (9)

Navigating the Frontier of Clinical Trial Data Management: Challenges and Innovations

Listen to a replay of this expert panel from Sanofi, Bayer, Daiichi Sankyo and Medidata as they delve into the dynamic clinical trial data management landscape. You will learn about the latest approaches and cutting-edge technologies that are now available to improve drug development and patient outcomes.

Watch the video

Accelerate Aggregated Patient Data Review

The Medidata Platform’s Patient Data Surveillance module includes Data Reviewer and Patient Profiles capabilities. Data Reviewer allows data managers to automate data review and reconciliation with AI and bulk query management. Patient Profiles enables intuitive, in-depth patient safety reviews across all data sources.

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Empowering The Transformation From Clinical Data Management To Clinical Data Science: We Have The Technology!

As the clinical trial data acquisition landscape expands, the industry requires new approaches to support the rapid pace and increasing diversity of data sources. Thus, it’s not surprising that the focus of clinical data management teams is shifting from reactive, exhaustive data cleaning to proactive, risk-based clinical data science.

Learn how Medidata empowers clinical data managers to transform into clinical data scientists and become more efficient, effective, and expert.

Read Article Read Blog Post

Risk Proofing Decision-Making

Protocol requirements often involve multiple data points from different data sources to determine screening criteria and calculate endpoint measurements. Multiple methods of data collection from sources like EDC, RTSM, eCOA, and Imaging increase data silos making it harder for site staff and study teams to access clean, reliable data and reducing the ability to make effective decisions This recorded presentation uses typical protocol requirements and illustrate the value of using the Medidata Clinical Cloud to collect and aggregate data to drive key study conduct decisions such as screening, open-label extensions, and cycle decisions.

Adaptive Trials

Adaptive designs leverage accumulating results during a study to adapt the course of the trial and benefit both early and confirmatory studies.

Medidata has extensive experience with adaptive trial designs. Our multidisciplinary expert teams can help with the planning and implementation of your adaptive design, so that common challenges and pitfalls are circumvented.

Read White Paper

Benefits of Rave Data Management

Reduced Risk Accelerated Timelines Agility and Flexibility Simplified Integration

Clinical Data Management | Medidata Solutions (14)

Reduced Risk

Reduce risk to data integrity, data quality and patient safety. The Medidata Platform delivers complete data transparency within a study or across a portfolio, empowering study teams to accelerate decision-making and drive study efficiencies, ultimately reducing risk and timelines.

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Accelerated Timelines

Managing all your data on a single, unified platform improves pace and productivity.

The Medidata Platform offers streamlined workflows enabling faster study build and database lock.

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Agility and Flexibility

Medidata’s platform meets the agility and flexibility needs of any trial. Medidata and our customers perform an average of over 30,000 mid-study changes per year, including for studies with tens of thousands of patients. The combination of our technology and experienced Professional Services team ensures smooth implementation of mid-study changes, with minimal downtime, for even the most complex, large-scale, and time-critical trials.

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Clinical Data Management | Medidata Solutions (17)

Simplified Integration

The Medidata Platform unified platform delivers full interoperability across our applications. It enables you to reduce redundancy and non-value added activities derived from data transfers, integrations and reconciliations common with disparate systems.

Medidata also has an open integration framework and APIs enabling integration with any in-house or 3rd party system.

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Products

Rave EDC

Rave EDC is the most advanced, robust, and secure system for clinical trial site, patient, and lab data capture and management.

Learn more about EDC

Patient Data Surveillance

Simplify complex data investigation and cleaning across many data sources with Patient Data Surveillance (PDS).

Learn More about PDS

Rave RTSM

Rave RTSM is the only fully pre-validated randomization and trial supply management solution that can be configured in minutes and enables mid-study changes with minimal downtime and no change orders.

Learn more about Rave RTSM

Medidata eCOA

Medidata eCOA (Clinical Outcome Assessment) is revolutionizing the way sponsors, CROs, and sites collect electronic data from patients, physicians, and caregivers.

Learn More About Medidata eCOA

Medidata eConsent

Medidata’s eConsent is an innovative, regulatory-compliant, patient-friendly, electronic consent system for clinical trials.

Learn More About Medidata eConsent

Medidata Sensor Cloud

Medidata Sensor Cloud takes a unique approach to the ingestion, standardization and scalability of data from any commercial or medical grade sensor device.

Learn More About Sensor Cloud

myMedidata

myMedidata is a single-destination patient portal, enabling patients to virtually enroll and participate in clinical trial activities.

Learn More About myMedidata

Rave Imaging

Rave Imaging provides cloud-based, secure management for all your medical imaging tasks in an innovative and intuitive system.

Learn More About Rave Imaging

Rave Coder

Rave Coder provides medical coding for verbatim terms from Rave EDC and external sources using the MedDRA, WHODrug and JDrug dictionaries.

Learn more about Rave Coder

Rave Safety Gateway

Rave Safety Gateway delivers precise, accurate, and efficient transmission of AEs and SAEs in Rave EDC to your safety system.

Learn more about Rave Safety Gateway

Site Cloud End of Study

Site Cloud End of Study (EOS) is the first end-to-end solution that seamlessly generates, distributes & manages study files at the end of a study.

Learn More About Site Cloud EOS

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Complex Trials Beyond EDC Medidata Explorer AI and Automation in Action

Revolutionizing Clinical Studies with Adaptive Trial Designs

Medidata has extensive experience with adaptive trial designs. Our multidisciplinary expert teams can help with the planning and implementation of your adaptive design, so that common challenges and pitfalls are circumvented. Discover the benefits of adaptive clinical trial designs. Maximize outcomes, efficacy, and patient safety.

Read Blog

NY NEXT Benefits Beyond EDC

The fireside chat will cover a pharmaceutical company’s experience on the decision-making process to move to the platform and what they have learned in the process, and a CRO will describe how it has positively impacted the study build, conduct and close out processes.

Personalized Assessment Tool

What are your biggest challenges and priorities for clinical data capture and management in your studies?

Explore our interactive tool to discover how Medidata’s solutions can help you address your specific challenges, and receive a personalized action plan.

Explore Now

Product Showcase: Innovation in Action: AI and Automation Delivers for Clinical Data Managers Today!

See how clinical data management teams can accelerate data review and focus on critical data insights using automation, AI, and analytics on the Medidata Platform.

Clinical Data Management | Medidata Solutions (2024)

FAQs

What is clinical data management? ›

Clinical data management (CDM) is the process of collecting and managing research data in accordance with regulatory standards to obtain quality information that is complete and error-free.

Which software is used in clinical data management? ›

Best Clinical Data Management Systems include:

Merative Zelta, Bioclinica ICL, Dotmatics Enterprise Data Platform, Oracle Clinical One and IQVIA Digital Site Suite.

What is Rave used for? ›

Rave is the standard electronic data capture system for all network groups in the NCI National Clinical Trials Network. These groups include the Alliance for Clinical Trials in Oncology, Children's Oncology Group, ECOG-ACRIN Cancer Research Group, NRG Oncology, and SWOG.

What are the three phases of clinical data management? ›

Clinical Data Management (CDM) is a critical phase in clinical research which results in collection of reliable, high-quality and statistically sound data. It consists of three phases i.e. start up, conduct and close out.

What degree do you need for clinical data management? ›

Clinical data managers have a variety of educational backgrounds and professional experience. Most have at a minimum master's degree in life sciences, computer science, or engineering. Some may have graduate certifications in areas such as clinical data management, health informatics, or biometrics.

What is a CDM job? ›

A clinical data manager (CDM) manages clinical trial data collection, processing and analysis. They play a critical role in developing new medical treatments by ensuring that clinical trial data is accurate, complete and compliant with regulatory requirements.

What are the best solutions for clinical data management? ›

Here are some key strategies for ensuring effective data management in clinical trials: Developing a detailed data management plan — This covers database design, data processing, quality checks, standards, security measures, timelines, and resource planning for the trial.

What is an example of data management in healthcare? ›

Health Data Management (HDM) is the methodical organization of health data in digital form. This can be anything from Electronic Health Records (EHR), Electronic Medical Records (EMR) generated as a result of doctor visits, to handwritten medical notes.

How to be a clinical data manager? ›

You need a combination of educational qualifications, training, and experience with clinical trials to become a clinical data manager. There are certificate and associate degree programs in data science, along with bachelor's and master's degree programs in IT, computer science, and data management.

Why is rave so good? ›

There is a collective energy in rave culture that is accentuated by uplifting music, common interests, drugs that promote positive serotonin experiences and you are usually with people you already like or can get lost in. PLUR, Peace, Love, Unity and Respect is something you will hear a lot of.

Who competes with Medidata? ›

Top 10 Alternatives to Medidata Rave Recently Reviewed By G2 Community
  • REDCap. (217)4.3 out of 5.
  • Medrio EDC. (100)4.4 out of 5.
  • Veeva Vault. (49)4.1 out of 5.
  • Castor. (116)4.6 out of 5.
  • Viedoc. (183)4.4 out of 5.
  • Egnyte. (980)4.4 out of 5.
  • OpenClinica. (24)4.2 out of 5.
  • Oracle Clinical. (29)4.1 out of 5.

What software is used in CDM? ›

Software tools such as Clinical Data Management System (CDMS), Clinical Trial Data Management System, Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Electronic Patient Reported Outcomes (ePRO) and Randomization and Trial Supply Management (RTSM) are used to support these activities.

What is the first step in clinical data management? ›

The creation of a study protocol, which includes the goals, methods for gathering data, and standards for data management for the clinical trial or research study, is the first step in the CDM process. Case Report Forms (CRFs) are created based on the study protocol.

What is Uat in clinical data management? ›

User Acceptance Testing (UAT) is a critical component in the clinical trial process. Its primary goal is to ensure that the Electronic Data Capture (EDC) system fulfills the requirements for a study.

What is work done in clinical data management? ›

Clinical data management consists of five stages, which span data collection, archiving, and presentation. The workflow starts when the CDM team generates a case report form (CRF) and ends when the database locks. The data manager executes quality checks and data cleaning throughout the workflow.

What is a CDM in healthcare? ›

The Charge Description Master (CDM) is a crucial component of the healthcare revenue cycle management (RCM) process. It is a comprehensive and centralized database that contains detailed information about the services and procedures provided by a healthcare organization, along with their corresponding charges.

What is the difference between CDI and MDM? ›

MDM and CDI

A broader term related to CDI is Master Data Management (MDM). Like the domain of customer data integration, MDM emphasizes the importance of congregating and maintaining a consistent view of a business's core entities that may be dispersed across a number of applications, services, and systems.

What is data management in healthcare? ›

Frequently asked questions: Why is healthcare data management important? Healthcare data management is the process of storing, protecting, and analyzing data pulled from diverse sources.

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