AboutLifeTree
About Lifetree - Who We Are Our Philosophy Executive Management Team: Alice A. Jackson, R.N. Lynn R. Webster, MD, FACPM, FASAM Matthew Iverson Sean Kotrady, CCRC, CCRP Neuroscience Research Team: Miroslav "Misha" Bačkonja, MD Mark A. Johnston, MD N. Lee Smith, MD Daniel B. Vine, MD Mary Jane Norman, MD Dennis Thoen, MD Debra F. Hobbins, DNP, APRN, LSAC, CARN-AP
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Medical and Safety Management

Medical Monitoring- Protecting You and Your Patients

We have MDs available to provide medical expertise for your studies. Our medical monitors provide medical consultation to investigational sites and the rest of the project team, including responses to questions regarding inclusion/exclusion of patients, review of lab data, and physician review of SAEs. Our physicians also have the experience and expertise to help you with protocol development, development of global safety plans, and regulatory submissions.

Lifetree provides these services via our preferred provider Synteract. Synteract’s medical monitors are medical experts who work as part of your team. They are available 24 hours a day, if necessary, so you can be comfortable that your study is covered by a safety expert you can trust and who is available to you.

Safety Surveillance - Your regulatory compliance in the hands of experts you can trust

Lifetree’s Safety Surveillance group is provided by Synteract and was formed to assist pharmaceutical companies in effectively tracking and managing their products’ benefits and risks. In today's competitive market, a reliable safety team with continuous, timely access to your data is a necessity. We have the expertise to manage all of your safety surveillance requirements, including case data capture, risk assessment, narrative preparation, MedWatch/CIOMS preparation, medical monitoring, and compliant regulatory reporting.

Our team of experienced pharmacovigilance experts consists of PharmDs, RNs, MDs, and other qualified safety personnel. Synteract employs Oracle AERS® software to collect, monitor, and manage safety data. This platform allows us to offer clients secure, real-time access to data and reporting tools via a standard web browser. Oracle AERS is a fully validated, high quality solution which, when backed by our team of experts, ensures that we stand by our promise of quality and flexible responsiveness to your needs.

As you take your products from pre-approval to post-marketing, from Phase I to Phase IV, Lifetree and Synteract have the tools and expertise to handle all of your safety surveillance and pharmacovigilance needs. We provide the assurance to you, patients, doctors, and regulators of the utmost safety tracking of your products.

Safety Surveillance Services:

  • Global Safety Plan development
  • Safety database development and management (Oracle AERS®)
  • Serious Adverse Event (SAE) case receipt, entry, processing
  • Preparation of case narratives, MedWatch, and CIOMS forms
  • Regulatory Submission preparation and reporting
  • Medical monitoring and medical SAE review
  • Reconciliation of SAE and clinical databases

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