Pharm-Olam Medical Affairs Ensures You Have the Critical Safety, Medical and Scientific Insight You Need.
Quality oversight of the safety, medical and scientific elements of your clinical trial is essential. At Pham-Olam, our medical affairs team serves as a keystone, working diligently to bring all the various elements of a trial together to enable you to reach success. We deliver consultation to help you ensure patient safety as well as the quality and integrity of your medical and scientific data. We will also work with you to confirm that the conduct of your trial remains consistent and follows the design of the protocol.
From pre-trial medical monitoring planning, objectives and endpoint identification, to in-trial protocol issues and clarifications, through to end-of-trial critical data and coding review, we provide rigor to guarantee your trial is done right.
Safeguard Your Trial With Comprehensive Medical Monitoring
To ensure the safety of the patients in your trial, we oversee the safety signals continuously throughout the study at both the individual patient and cumulative/group/study level. Individual data supports detailed patient profiles, while group/study data provides insight that our teams use for safety trending, analysis and anomaly detection.
Consultation can take on many different aspects as it relates to the completion of your clinical trial. Our medical monitors will consult with you as well as project teams and sites on the preparation and conduct of your trial, generating solutions that benefit site performance, patient enrollment, protocol adherence and study efficiency while keeping study participants safety in focus.
For therapeutically driven consultation, protocol development and design services questions, Pharm-Olam leverages our in-house experts and can augment with external consultants to provide you with the best solutions. Our medical affairs team is aligned to support and guide you in collaboration with our Centers of Excellence (CoEs). We have therapeutic specialists in place for rare and orphan diseases, Oncology-Hematology, Infectious Disease & Vaccines, and Respiratory-Allergy, among other therapeutic areas.
How Do We Support Medical Monitoring?
We Pair Expert Staff With the Right Technology
To carry out medical monitoring that ensures the safety, accuracy and integrity of your trial, we employ knowledgeable staff, execute effective processes and utilize the best cutting-edge technologies. Pharm-Olam is the only CRO in industry to fully leverage the Medidata Rave Clinical CloudTM. Sponsors and our Medical Affairs team will benefit from Medidata technologies such as:
Rave Design Optimizerto enhance your objective and efficient study design choices leveraging benchmark data and analytics
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 Gatewaycreates a direct connection between electronic data capture (EDC) and the safety database, dramatically reducing error rates while improving overall data quality and reducing overall case processing time
Rave RBMsupports Pharm-Olam's execution and management of Risk Based Monitoring strategies and tactics where medical monitoring staff can follow and check trending
How Pharm-Olam Medical Monitoring Serves Our Sites & Patients
Pharm-Olam takes our support of patient enrollment seriously and it starts with our hands-on approach to supporting sites' review of patient eligibility. Every patient matters especially in the challenging therapeutic areas that Pharm-Olam focuses, and therefore we work closely with sites and commonly set-up pre-screening processes where our MDs support sites in qualifying/finding the right patients for study participation. This leads to lower screen failure rates and on-time enrollment delivery. Additionally, our hands-on approach minimizes protocol deviations, and ensures the highest possible data quality.
In addition to a rigorous eligibility review, our 24/7/365 coverage ensures you and your sites can reach a medical expert at any time. Whether it is a question about GCP, safety and reporting or unblinding a patient, our medical team is available and responsive. We have a specific coverage plan for every study, so callers will be able to connect with the medic that is directly responsible for their study.
Finally, Pharm-Olam medical affairs leverages the power of the Medidata Rave Clinical Cloud platform to enable oversite and protection of patient safety, and enhancement of data quality and integrity for your trials. You expect safety, efficiency and accuracy for your trials; Pharm-Olam delivers all of that and more.
In need of a partner to support your sites and patients?
Our medical team is dedicated to the sites and patients we serve. Talk with our team today.