Heor | Pharma & Vendor Perspective
We’re looking to speak with 2 experts (one from a pharma company and one from a vendor) to begin with who have a good idea about outsourcing opportunities present within the heor (health economics and outcomes research) segment.
This would be for a 1 - hour paid phone consult. Please respond with a few brief statements as to your relevance in this space.
1. Can you discuss the different services within the heor function and who are the key players in europe/us?
2. Would you be able to explain the spend by phase/activity/expected peak sales/company size
a. For example: what is the spend on rwe/rwd analysis and htas by phase/peak sales of a given molecule
3. Can you share your insights on mega trends/tech disruption in the segment because of ai/ml
a. How has the market evolved over the last 3 years and where is it headed in the coming 3 years?
Companies: novartis, pfizer, jazz pharmaceuticals, allergan, amgen, celgene
vendors: parexel, evidera, iqvia, drg, laser analytica
note: we are looking to speak only with us/eu experts.+37 Other Responses
This is a full-time employment opportunity for a clinical trial manager (ctm) in the san francisco area.
-responsible for coordinating and monitoring the day-to-day logistics of our clinical trials.
-manage clinical trial operations including vendor performance, internal/external metrics, and communication of project status within the project team
-manage and track completion of study start-up, conduct, and closeout activities to industry and corporate standards
-ensure the progress and completion of projects according to timelines
-prepare and present project specific updates
-lead or assist in the writing of clinical documents such as protocols, study reports, study manuals, and annual reports
-monitor safety surveillance and reporting activities
-oversee data management processes including collection and cleaning of clinical database, reconciliation of clinical and safety databases, and data interpretation and evaluation
-coordinate dsmb/safety reviews inline with charter and overall study parameters
-assist in the construction of clinical development processes including development and writing of sops, creation and organization of study trial master files, and clarification of organization and workflow structures
-plan, generate, and track study timelines and trial budgets
-site management activities including: review monitoring reports, interact with study monitors, track site errors or other indicators of site difficulties, identification of potential problem sites and development of corrective action plans as required, acting as our contact, as needed, for clinical sites
-ba/bs degree in biological science or nursing required (equivalent experience may be accepted)
-5+ years of clinical research in the biotechnology/pharmaceutical industry
-3+ years of multi-center clinical trial management experience, specifically experience in phase 2, phase 3 us & international clinical trials
-experience managing cros, central laboratories, and other clinical study vendors
-experience preparing clinical trial budgets and contracts
-knowledge of ich-gcps and 21 cfr is required
-experience in metabolic/hepatic drug development is desirable
-experience with ivrs and/or edc is desirable+24 Other Responses
Cro Outsourcing In Clinical Trial
We are a market research company looking for the following information pertaining to cros on behalf of our client:
unique cro outsourcing trends in the clinical trial (cro) industry where cros have been innovative in how they offer services to pharmaceutical companies; real life examples between cros and pharmaceutical companies
preferred or approved supplier for major pharmaceutical companies
how other pharmaceutical companies validate cro rates without going out to bid?
Supplier analysis and market analysis
+24 Other Responses