Can Medidata’s DCT solution support hybrid trial designs?

Yes. The program is designed to be scalable and flexible, allowing you to virtualize as much or as little of a clinical trial as needed. It supports a hybrid approach through unified technologies like Medidata eConsent, eCOA, and Sensors solutions, ensuring high-quality data collection regardless of geography or trial complexity.

Does Medidata offer access to a network of DCT-ready sites?

Yes. Through a partnership with Circuit Clinical, Medidata provides a turnkey solution that includes a national network of decentralized sites. These sites are already trained and certified on Medidata technology, which enhances patient access and inclusion while ensuring standardization across the study.

How does the platform handle direct-to-patient (DtP) supply management?

Medidata RTSM features robust DtP capabilities that offer high flexibility for decentralized and hybrid trials. It allows shipments to be triggered at the site, visit, or patient level, and enables patients to confirm incoming shipments directly through their myMedidata account.

How does the solution ensure data quality with remote monitoring?

Medidata addresses data quality challenges in DCTs through centralized, remote, and risk-based monitoring (RBQM) capabilities built on a unified platform. This allows study teams to shift from 100% on-site monitoring to remote oversight activities without sacrificing timelines or data integrity.

Does Medidata offer training for its clients and partners?

Yes. Medidata offers a variety of training options for our clients and partners, including both self-paced and instructor-led courses. To learn more about available courses and to access our resources, please visit the Medidata Global Education and Training section.

Decentralized Clinical Trials - Flexible, Patient-First Design

For Sponsors: 
Control and Confidence

Centralized oversight helps sponsors maintain compliance, data integrity, and patient safety—while scaling decentralized, hybrid, or fully remote trials with confidence.

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Video transcript: Felix is a trial manager at Carbon Pharma. His portfolio includes a basal cell carcinoma study with a protocol using a decentralized clinical trial model for trial activities. Felix wants to provide the best experience for patients and sites, including technology that is easy to use and flexible. He's pleased to include Medidata's technology since it puts sites and patients on the same platform. Felix also notes that Medidata's electronic data capture system, RAVE EDC, and other data capture tools will be utilized, and is excited to see that there are multiple sensors in this study, reducing the burden on the patient while improving the quality and amount of data received. Felix sets up a My Medidata pretrial registry to engage, empower, and educate patients on basal cell carcinoma clinical trial opportunities. By setting this registry up in advance of the trial, Felix is enabling faster enrollment as study start up activities progress. He also has goals to include patients from underserved communities. When looking through his list of sites, Felix is pleased to see that Doctor. Aliyah will be participating in the research study, given his prior experience with Medidata's suite of decentralized clinical trial solutions. Felix notes that several circuit clinical sites are also participating in the study, all trained on Medidata's technology. Felix is able to monitor Doctor. Eliya's enrollment in the study, as well as data received in RAVE EDC. He is confident that he will meet his goals for the study start up and reaching underserved patients. Wei is a biostatistician at Carbon Pharma. She works very closely with Felix and the data management team to monitor all study data to spot any potential issues. Wei appreciates the analytic capabilities Medidata has to offer, built directly on the same platform as the data capture tools, giving her real time intelligence into trial performance and data quality. One day, Wei receives an alert through Medidata's centralized monitoring tool that a high volume analysis of data has spotted an unusual finding at Doctor. Aliyah's site. Way raises an issue with Carmela, a data manager from Carbon Pharma, and Felix, the trial manager, detailing the issue and requesting a further investigation with site staff. This ultimately leads to the retraining of the sites and patients, correcting future issues and putting the trial back on track. Following completion of the study, Felix issues an authorization for patient data to be returned to the participant through their My Medidata account. Felix is proud of his work in this patient centric study.

Sites

For Sites:
Operationally Sound

Integrated workflows help sites manage remote activity, home visits, and quality data collection without juggling disconnected systems or adding administrative burden.

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Video transcript: Doctor. Aliyah is a physician at Gray Memorial. He's an oncologist with twenty years of traditional clinical trial experience. He has a busy practice, balancing his clinical trial visits with his ever growing patient population. His site was recently selected to join a basal cell carcinoma research study. The research study is set to run as a decentralized clinical trial where patients will be engaged virtually for some parts of the trial. Using Medidata technology, his staff will have one system to view all patient data, eliminating the need for learning multiple applications, each with its own login. By putting patients and sites on the same platform, study teams can easily connect with patients remotely while managing data with fewer integrations. This enables Doctor. Aliyah and his staff to focus on patient care and reduces manual data reentry. One morning, Doctor. Aliyah's study coordinator, Casey, receives a notification that a new patient named Lisa has matched the study through My Medidata registries. Casey reviews Lisa's electronic medical records and self reported information with Doctor. Aliyah, and they decide to set up a video visit to meet with Lisa and discuss the details of the study. With such a busy practice, Doctor. Aliyah is relieved to be able to see a new patient remotely, especially since Lisa lives two and a half hours away from his clinic. Doctor. Aliyah explains the consent process to Lisa and asks her to watch the video and then discuss the study opportunity with her loved ones. Through Medidata's unified cloud based platform, Doctor. Aliyah is able to see a complete view of Lisa's health information in a single location. This simplifies the prescreening process and allows Doctor. Aliyah to make recommendations to Lisa more easily. A few days later, Doctor. Aliyah receives a notification that Lisa has electronically signed her consent form through her My Medidata account. Doctor. Aliyah countersigns the consent form electronically and sends Lisa a copy through My Medidata. Now that Lisa is a participant in the study, Doctor. Aliyah meets with her according to the protocol schedule of events, but in a decentralized model. Some visits take place at the hospital and some visits Lisa completes at home, with medication being shipped directly to her using Medidata's platform. Using MyMedidata, Doctor. Aliyah can monitor her basal cell carcinoma progress through measurements of her uploaded tumor images and sensor data without the need for Lisa to come into the office. With this consistent and simple access to real time data, Doctor. Aliyah and Lisa feel confident this clinical trial is a good option for Lisa. One day, Carmilla, a data manager, and Felix, the trial manager from Carbon Pharma, call Casey to discuss discrepancies in patient diary responses. Applying advanced analytics to the study data as it's collected in real time, Medidata's centralized monitoring tool automatically identified outliers in the patient diary responses and alerted Carmella to a potential issue. It appears that several patients had not been completing their patient diary responses correctly and were not answering key questions. As a result, Doctor. Aliyah and Casey feel more participant training is needed and contact patients in the study, including Lisa, to review diary responses through a video visit. By using this technology, Lisa and other patients were able to confirm their health status without the need to travel to a study site, and the study data quality was not compromised. After her last study visit, Doctor. Aliyah thanks Lisa for her participation and reminds her to stay engaged with her registry to receive her study data and other updates and learn about new clinical trial opportunities.

Patients

For Patients: 
Simple by Design

Simple, intuitive tools reduce friction for participants of all ages, supporting consent, assessments, and remote data capture without overwhelming them.

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Video transcript: Lisa has been an oncology patient for three years and takes an active role in her health care. Lisa recently joined the MyMedidata Registry to learn more about clinical trials so she can find a research study that may be a good fit for her. One day, Lisa receives a notification from MyMedidata about a study that may be of interest to her. Lisa shows her doctor the information about the trial she received from MyMedI Data. They discuss the trial and determine it could be a good fit, but realize the study research center is a two and a half hour drive away from Lisa's home. Lisa's doctor calls the primary investigator of the study, Doctor. Aliyah, to discuss the trial and determine if Lisa may be a good candidate for participation. Doctor. Aliyah and Lisa connect directly over a My Medidata Live Video Call to review the study information. Doctor. Aliyah explains the consent process to Lisa and asks her to watch the video and discuss the study opportunity with her loved ones. Lisa watches the video and decides she wants to participate and signs the eConsent form through her My Medidata account. Lisa also consents to link her electronic health record data, such as previous surgeries or other medical related information, to her clinical trial data through Medidata Link in order to allow researchers to learn more about her health and possibly remove the need for extra clinic visits. Doctor. Aliyah checks Lisa's electronic health record, EHR information, and transfers relevant data into RAVE EDC, the electronic data capture system. Lisa is now a participant in the study. Using a hybrid decentralized clinical trial model, she has some visits in the clinic and some at home with medication and other study supplies being shipped directly to her home. Out of the five site visits required in the study protocol, she is able to complete three at home. This flexibility significantly reduces Lisa's travel burden and saves her from needing to take several days off from her job. She wears a sensor to collect some data information and she enters some into a study diary application on her phone. During study visits on-site and through video visits, Aliyah and Casey, the study coordinator, enter information into Ray VDC. Her study doctor can also see her diary responses, as well as her sensor and image data, all in one place. It's easy for Doctor. Aliyah to see how Lisa is doing in the study. Once Lisa has completed her clinical trial, she transitions from the study into long term follow-up through My Medidata registries. She learns that the medication was approved and her participation helped many others. She also receives her clinical trial data back and is able to keep access to it on her MyMedidata account where she can share it with her primary care doctor. Lisa is happy with how much support she received through every step of her clinical trial journey. Because of this, she's even more interested in joining future clinical trials.

Platform

Resources

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Decentralized Clinical Trials

Run Your DCT
from One Platform

Suite of Patient Engagement Solutions

Continuous Clinical Data Monitoring

Direct-to-patient (DtP) Investigational Product Delivery

Circuit Clinical Partnership for Turnkey Solution

Flexible, Custom Design with Medidata’s Trial Dial™

Built to Ease Complexity for Everyone