Manage Your Safety Data With Our Innovative Approach - Helping You Create a Healthier World
Faster, Smarter Pharmacovigilance Reporting With Innovative Technology
Pharm-Olam combines the expertise of our staff with superior technology. Our pharmacovigilance services are powered by theMedidata Rave® Safety Gateway, a cloud-based data platform, which is connected to our safety database, theArisGlobal LifeSphere®platform. Rave Safety Gateway creates a direct connection from the Medidata Rave EDC to our LifeSphere safety database. By leveraging these three enabling technologies together, we are able to offer our Sponsors the following benefits:
Case handling time is decreased by up to 30%
Information is received faster
Data entry errors between systems are prevented
Data records are simplified because investigator data, demographics, AEs or SAEs, concomitant medications, and medical histories are already entered and coded
Site burden is decreased
Queries process is more efficient and streamlined for sites and staff
Cases can be closed faster and more efficiently
Your study's safety data is maintained from a single source of truth
Industry Leading Deployment Timeline
Give Us Five Days. We’ll Give You a Safety Database.
Our 10-year history with ArisGlobal LifeSphere® allows us to leverage this powerful platform to its fullest potential. How soon can your study be up and running?
Pharm-Olam leads the industry with a record-breaking turnaround time of five business days from the time we are awarded your business to the creation of a fully functional safety database.
You deserve a partner who knows FDA regulations inside and out. Our U.S.-based team has worked for more than 30 years within the postmarketing and medical information area. Our impeccable record includes multiple successful FDA audits with zero findings in support of post marketing and medical information activities.
When you work with our team, you receive the highest level of accuracy and reporting because, just like our pharmacovigilance clinical trial counterparts, we leverage the ArisGlobal LifeSphere® platform for our safety and medical information database. This efficient electronic solution increases data accuracy and dramatically reduces discrepancies.
Our medical information call center is comprised of health care professionals and drug safety officers who are trained to deliver specialized information. Whether callers are pharmacists or customers, they receive the right answer, right when it's needed. Our team can also work with a sponsor’s existing medical information center to help and assist with calls or call backs.
Best of all, our postmarketing and medical information team is available 24 hours a day, seven days a week to provide help and answers to questions.
Pharmacovigilance and Post Marketing Services
Pharmacovigilance Services That Have You Covered
Whether you need help with a Phase I clinical project, postmarketing, or anything in between, our pharmacovigilance teams deliver a complete range of services designed to ensure patient safety is covered in every stage of the drug life cycle.
Clinical Development Pharmacovigilance
Customized safety surveillance
Safety narrative writing
Safety signal management
Aggregate report management
Individual case reporting
Call center function
Safety database services
Social media listening and monitoring
Clinical adjudication committee management
Product inquiry response and management
Product complaint intake and management
Adverse event intake
Medical information response letters
Product recall and crisis planning
Adverse event and product complaint management
Literature monitoring and media monitoring search
Poison control services
“We trust Pharm-Olam's PCV expertise to ensure the safety of our Product in the marketplace. The Pharm-Olam team is very responsive and professional!”
Biotech - Senior Regulatory Compliance Specialist
How can our pharmacovigilance team help you?
We have the expertise you can trust and the expertise that delivers. Talk with our team today.