Orbis Clinical Case Studies
Current Independent Safety Review Engagement. Increase in Signals necessitate Independent Safety Review to ensure successful completion of Phase III trial
Client: Global Biopharmaceutical Company
Location: Southern California
Solution Provided: Retained by client to independently review data from a blinded Phase III trial as a result of a spike in signals that jeopardize the success of the trial. Based on a comprehensive download of information pertaining to the trial itself and the challenges faced by the client, Orbis outlines a detailed solution aimed at reviewing CRFs (Case Report Forms) and adjudicating AEs/SAEs selected by client. Being a blinded study, Orbis reviews adjudicates AEs/SAEs according to distribution of events by Group A/Group B and provides a recommendation to the client.
Planned NDA and lack of experienced Labeling talent create an immediate need for a Labeling Expert
Client: Growing Biotechnology Company
Location: Philadelphia Area
Services Provided: Our client had aggressive deadlines set for the creation of a new label in support of an upcoming NDA. Orbis Clinical introduced an accomplished Labeling expert who quickly organized the project and ultimately developed/delivered a high-quality label.
Our client required a virtual bench of Safety Physicians to address on-going post marketed reporting requirements.
Client: Major Pharmaceutical Company
Location: Mid West
Services Provided: Created a virtual bench of experienced, qualified, safety physicians to address on going post marketed reporting requirements. These physicians are introduced on short notice to assist client team with sudden spikes in workload. Client continues to meet all deadlines for various regulatory response and reporting requirements.
Restructuring of a Drug Safety & Risk Management organization requires Drug Safety Physician expertise
Client: Major Biopharmaceutical Company
Location: Cambridge
Services Provided: The restructuring of an existing Drug/Clinical Safety organization coupled with changing licensing agreements with partners creates the need for a team of 4 experienced Drug Safety Physicians. Orbis Clinical successfully assembled a team of 4 Physicians to perform both case review and aggregate data review.
Provide team of 15 Drug Safety consultants with legal documentation experience to assist client with a high-profile drug litigation project
Client: Major Pharmaceutical Company
Location: Tri-State Area
Services Provided: Retained by client to assemble a 12-15 person team of drug safety professionals (depending on case load) to help its legal department with preparation of responses to Summons & Complaints. Based on specific client challenges, Orbis Clinical provided a team comprised of Data Registrars, Medical Report Coordinators, and Drug Safety Specialists. As a niche provider of drug litigation services, these contract consultants were provided under a Clinical Service Agreement (CSA).
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