Clinical Data Management Services

Providing You with Deeper Data Insights to Create a Healthier World.

When it comes to clinical data management, experience is key. Our data management team is led by seasoned experts with more than 20 years’ experience, which means you can rely on Pharm-Olam to flexibly meet all your study needs. We advise and apply best practices to improve study efficiency and maximize data collection and accuracy. And, we provide complete transparency so that you always have full access to your data. Nowhere else will you find the kind of measurable information we have available to you at all times for your study.

Furthermore, because we continuously and proactively clean your database, we provide you with extremely clean analyses of your patient data during the life cycle of your study and lock your data efficiently and quickly — allowing us to meet your aggressive timelines.

Leveraging Industry Leading Clinical Technology

Powered By Medidata

We are one of the first CROs in the industry to fully leverage the full power of the Medidata Rave Clinical Cloud^TM. To provide you with the best data management, we leverage these Medidata tools:

Rave EDC leads the industry with nearly 50% of all clinical trials running on this comprehensive data collection suite
Rave Coder expedites our coding process by streamlining coding workflows, queries, reconciliation, and is backed by machine learning
Rave Randomization Trial Management System (RTSM) integrates seamlessly with the EDC system enabling users to perform IP (investigational product) accountability and reconciliation
Rave eCOA supports flexible device deployment, customization and best-in-class software to support the collection of critically important patient reported outcomes
Rave Centralized Statistical Analytics (CSA) supports our ability and yours to interrogate the data coming in from all sources and leverages machine learning for advanced anomaly detection and generation of detailed patient profiles as well as study and site-level dashboards
Rave Safety Gateway creates a direct connection between the EDC and safety databases, dramatically reducing error rates, duplicative entry while improving safety and reporting
Rave RBM supports Pharm-Olam's execution and management of Risk Based Monitoring strategies and tactics where all project staff, including you, can follow and check trending

In addition to our partnership with Medidata, we also have experience with additional systems. If you choose to use other options, we’ll work flexibly according to your preferences to provide you with the insights and clean data your trial demands.

Access, Reporting and Analysis

Gain Real-Time Access to Your Data With Unmatched Reporting and Analysis

Combining our clinical data management services with industry-leading technology through the Medidata Rave Clinical Cloud, we give you on-time, on-demand reporting and in-depth insight into your trial. You will have 24/7 access to the systems mentioned earlier where you can utilize the advanced data integration and dynamic dashboards. This way you will always know the status of your trial. Making evidence-based decisions is critical to the success or failure of your study. At Pharm-Olam, we offer you an exceptional team combined with the best technology to support your study needs.

Living in the Data

Our Approach to Achieve Quality Data

During your clinical trial, we live in your data. We are constantly cleaning your data from the start of the study by using a rolling data lock approach — cleaning your data and locking patients’ data daily. You will know that at all times your data is as clean as possible — and because you have unlimited access — you can confidently review and generate reports to stay abreast of your sites, analyze your data and share with your stakeholders. And, we invite you to do it all on your schedule, not ours.

Also, our data team’s SAS-experienced programmers delve deep into your data to provide you with additional insight. Custom reports are available from our dedicated DM SAS programming capabilities.

We also provide our proprietary Clean Subject Tracker, maintained by our SAS programming team. With this tool, you can see your clean data and which components remain incomplete — down to a single patient at a single site. Gain additional insight into the overall status of your trial and be confident of your data readiness.

Pharm-Olam’s spirit of openness extends to sites as well. Our team is always available to answer questions or help resolve issues. We're here to help you create a healthier world by giving you limitless access to your data and to our team whenever you have questions in order for you to make the best decisions for your clinical trial. That’s how we support you.

Data Management FSP

Experience Ease With Data Management Functional Services

When you seek a quality solution to your clinical trial data management, you can turn to Pharm-Olam’s data management team. We support sponsors and the functional outsourcing of data management with a flexibility that makes outsourcing simple, whether you need support for a single task or if you require complete data management for your next study.

With demonstrated expertise, we have the capabilities to manage your work and meet your timelines. And, we will scale to fit your needs and budget.

Our Culture of Accountability

Means Empowerment and Dedication

Both inquisitive and passionate about our work, our team is constantly seeking to go beyond to find better options and initiatives. Pharm-Olam’s Culture of Accountability empowers our team to proactively resolve issues — working with third-party vendors, with sites and with other teams. Leveraging the tools within the Medidata Rave Clinical Cloud, our team continuously looks for anomalous data and brings forward solutions to manage your study as if it were our own.

To learn more about the Culture of Accountability and how it fits within our Pattern of Excellence, click the button below.

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Sponsor Testimonial

“We found the data quality and adherence to the protocol outstanding.”

Biotech - Executive Vice President

Risk Management & Bow Tie Methodology

Be Audit-Ready With Proactive Risk Management

Managing risk is a critical part of your data management plan, which is at the forefront of how our team manages your project. We have safeguards in place for how we validate the program and how we perform user acceptance testing, for example, and we document extensively so that you can be confident we follow SOPs 100% of the time. Audit-ready at any moment, we confidently welcome database audits because we know your data is consistent, accurate and protected.

Like many other teams at Pharm-Olam, one of the tools our data management team uses to manage risk is the bowtie method, a visual communication tool that identifies potential risks, their associated consequences and the controls that must be in place to manage that risk. Besides the obvious benefit of managing your risk, you are able to transparently see how our data management team is planning proactively for risks associated with your particular product. Moreover, you gain additional confidence in your data integrity.

To learn more about the Bow Tie methodology and how it fits within our Pattern of Excellence, click the button below.