Medidata Therapeutic Solutions

Medidata Therapeutic Solutions are designed to tackle the complexities of oncology and vaccine clinical trials safely and cost-effectively.

Medidata Therapeutic Solutions provides an integrated, cost-effective approach to supporting Phase 2 and Phase 3 oncology and vaccine studies. They help sponsors and CROs manage the rapid pace of research while focusing on regulatory compliance, patient safety, trial efficiency, and delivering life-saving treatments.

Four of Medidata’s powerful and innovative solutions – Clinical Data Studio, Medidata eCOA, Rave Imaging, and Health Record Connect – are bundled to drive oncology and vaccine trial quality and efficiency. Working with Rave EDC, these solutions provide the core of an efficient, cost-effective approach to accelerating your oncology and vaccine trials. Medidata Therapeutic Solutions offers a robust, integrated approach to managing your trials, with the added benefits of significant cost savings, scalability, and comprehensive support. This synergy simplifies the trial process and enhances the quality and reliability of trial outcomes.

In addition to the core solutions mentioned above, many other Medidata solutions, such as RTSM, eConsent, Medidata Link, Interim Lock, and Synthetic Control Arm, can be added to the bundle to cost-effectively and safely accelerate your trials.

Challenges

Sponsors and CROs face many challenges in rapidly and successfully executing oncology and vaccine trials, including trial design and curation, data complexity, patient recruitment, and the growing need for real-world data integration. The following table is a summary of these challenges by trial type:

Oncology Vaccines

Trial Design and Duration

Rare cancers, slow recruitment, adaptive protocols. Disparate technologies to support complexities.

Data Complexity and Monitoring

Complex data (genomics, biomarkers, imaging). Real-time monitoring of safety and efficacy.

Patient Recruitment and Retention

Small/scarce populations, slow recruitment, higher patient burden, and dropout rates.

Regulatory Requirements

High regulatory oversight, fast-track pathways.

Real-world Data Integration

Long-term efficacy, post-market surveillance, and diverse patient outcomes.

Trial Design and Duration

Large-scale, multi-country, rapid recruitment, especially in pandemics

Data Complexity and Monitoring

Focus on safety and immunogenicity with large populations, monitor rare events

Patient Recruitment and Retention

Recruit diverse healthy/at-risk populations quickly across regions

Regulatory Requirements

Comply with global regulatory standards, including emergency use during pandemics

Real-world Data Integration

Need to understand long-term vaccine effectiveness, monitor safety across diverse populations, and assess outcomes

Medidata Healthcare and Therapeutic Solutions Help Solve These Challenges

Unified Data Ecosystem

Rave EDC and Clinical Data Studio (data surveillance and data quality management) working in unison on a single cloud-based platform ensures seamless data flow and harmonization, minimizing data silos and reducing the complexity of data review and reconciliation, leading to more efficient and accurate trial outcomes.

Enhanced Patient Engagement and Data Accuracy

Medidata eCOA allows for real-time patient-reported outcomes, which are critical in oncology and vaccine trials where patient quality of life and symptom tracking are paramount. Integrating Rave EDC with Health Record Connect ensures that patient data is captured accurately at the site and seamlessly integrated with clinical data, providing a holistic view of patient health.

Streamlined Imaging and Data Management

Oncology trials rely heavily on imaging to assess tumor progression and treatment efficacy. The integrated Rave Imaging allows for centralized collection, management, and analysis of imaging data. This synergy reduces the need for manual data transfer. Medidata eCOA with Image Capture allows the real-time image collection of potential reactions at vaccine injection sites or systematic allergic responses critical to tracking adverse events identified in study protocols.

Scalability

By offering these solutions on the unified Medidata Platform, the oncology and vaccine bundles provide scalability that meets the needs of trials of varying sizes and complexities. Sponsors and CROs can start with a small Phase 2 trial and quickly scale to a large, global pivotal trial as needed without worrying about integrating additional systems.

Comprehensive Support and Optimization

Optional Professional Services ensures that Sponsors can fully leverage the bundle’s capabilities. These services guide Sponsors in optimizing the use of each solution, ensuring that the trial process is more efficient and compliant with regulatory standards.

Regulatory Readiness and Compliance

Oncology studies and vaccine trials are tightly regulated. Medidata Therapeutic Solutions ensures compliance across all stages—from data collection to reporting—minimizing non-compliance risks and speeding up approvals.

Pricing

Medidata Therapeutic Solutions provides discounted pricing for its core solutions and any optional ones chosen to help support your oncology and vaccine trials.

Experience

Medidata’s experience and expertise in oncology and vaccine trials are unparalleled and foundational to Medidata Therapeutic Solutions.

25+

Experience

Years of oncology and vaccine experience

9,000

Trials

Oncology trials supported

1 Million

Patients

Vaccine patients supported

655+

Vaccines

COVID-19-related vaccine trials

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