Global Medical Affairs
The QPS Global Medical Affairs (GMA) team cares about your unique clinical development program and the patients you serve. Our team of experienced scientific and medical experts can provide strategic advice and clinical development support to ensure your clinical study success and enhance your custom-built research.
Why You Need a Global Medical Affairs Partner
Precision is key when exploring patient care solutions. With that in mind, QPS offers a full suite of GMA services to drive innovative asset development, along with external and internal stakeholder engagement, driving our clients toward precise, groundbreaking research outcomes.
As a GMA team, we are known for our scientific and medical expertise. Our team of scientists, physicians, and clinical research professionals has deep expertise in clinical study design, asset development strategy, study conduct, medical management and safety oversight. Our approach to client partnerships centers around personalized support, leveraging agile and innovative solutions. We offer partnerships to meet individual client needs throughout the development lifecycle, providing strong support and a range of capabilities from clinical study to external stakeholder services.
Through our custom-built solutions, we deliver a full suite of medical affairs services to drive your asset development and external stakeholder management.
Renowned Scientific and Medical Expertise
Our team of experienced scientists, physicians and clinical research professionals has deep expertise in clinical study design, asset development strategy, study conduct, medical management and safety oversight.
Personalized Support Through Agile & Innovative Solutions
We offer partnerships to meet individual client needs throughout the development lifecycle, including level of support and range of capabilities from clinical study to external stakeholder services.
The Global Medical Affairs Process
Enhance enrollment I Improve execution I Enable go-to-market success
Inclusion/exclusion criteria I Patient population I Sample size I Clinical assessments I Study endpoints I Study design
Advisory boards I KOL consulting I Asset strategy I Study design I Protocols I Study data I Competitive landscape
Clinical profile I SWOT I Market size I Market gaps I Framework for regulatory discussions
Market opportunity assessment I Gap analysis support
Clinical Study Protocol (CSP) I Clinical Study Report (CSR) I Investigator Brochure (IB) I Informed Consent Form (ICF) I Topline Data Readouts
Medical monitoring plan I Project team training I Study team meetings I Safety review meetings I PI/CRA medical support I Data review (individual, aggregate and trends)
SAE intake, processing, and medical assessment I Safety data analysis and aggregate reporting I Safety reporting to regulatory authorities I Pharmacovigilance (PV) services
Pivotal manuscript development I Post-hoc analyses publications I RWE publications I Disease State and Treatment Landscapes
Abstracts I Posters I Presentations I Symposia
Medical education I Disease state education I Therapy area education
Feasibility I Site Selection I Site Management I Clinical Trial Kits I Clinical Staff Training
Post-Marketing Observational Studies (PMOS) I Non-interventional Studies (NIS) I Agency Post-Marketing Requests I Pregnancy Registries
Patient needs I High quality patient insights
QPS Global Medical Affairs Services
We offer partnerships to meet individual client needs throughout the development lifecycle, from study design to ongoing patient advocacy:
Early Phase Clinical (Phase I – IIa)
- Study design
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KOL engagement
Relationships
Trial sites
Protocol input -
Early advocacy building
Disease states
Unmet patient needs
Post-Approval
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Post-Approval Evidence Generation
Real World Evidence - Registries, PMOS, NIS
Ph IIIb/IV Studies
Investigator Initiated Studies -
Medical Education
Labels/Package Inserts
Ph III Data
Appropriate Patient Types -
Medical Communication
Pubs: Data Cuts to Address Key Gaps - Advocacy and Patient Engagement
Late Phase Clinical (Phase IIb – IV)
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Early Phase Clinical support
Study design
Trial sites
Target Product Profiles -
Medical communication
Publishing Phase II/III/IV data -
Advisory Boards
Scientific Narrative
Competitive Differentiation -
Medical Education
Disease States
Treatment Landscapes - Gap Assessments
Our team cares about your individual program needs, and we are dedicated to forming a strategic partnership to elevate your development strategy. Our team of experienced scientists, physicians, and clinical research professionals has deep expertise in clinical study design, asset development strategy, study conduct, medical management, and safety oversight. Contact us today and we will set up a meeting to get started.
