Your Pharmaceutical Physician Consulting Company
MedSurgPI provides medical consulting for product development and medical affairs including fractional chief medical officers, medical monitoring, medical communications and medical input for promotional (LMR) review.
Schedule a meeting to see how MedSurgPI can help you!
Product Development
DRUGS & BIOLOGICS | DEVICES | DIAGNOSTICS
Medical expertise for clinical strategy, protocol review and development, FDA meetings, sponsor interaction, presentation at investigator meetings, CRA training, data and coding review, CSR review, advisory committees, DSMBs, SRCs.
Fractional (Functional) Medical Services
Fractional medical services to include Chief Medical Officer, Medical Monitor, Medical Director.
• CRO Selection and Management
• Safety: Data Safety Monitoring Board (DSMB), Clinical Safety Review Committee (CSR), Clinical Events Committee (CEC)
Medical Affairs
• Medical Communications: Journal articles, White Papers, Blogs, Conference Podium Presentations and Posters
• Legal Medical Regulatory Review (LMR): for review of advertising and promotional material
• Key Opinion Leader (KOL) selection and management
• Continuing Medical Education (CME)
• Speakers Bureau
Data and Safety Monitoring Board (DSMB)
MedSurgPI has comprehensive DSMB services, bringing together an elite team of experienced physician specialists, statisticians, and pharmacokinetic experts dedicated to serving as your DSMB.
What they offer:
• Expertise
• Comprehensive Services
• Customized Solutions
• DSMB Charter Creation
• Efficient Administration
• Timely Communication
• Regulatory Compliance
Gerald L. Klein, MD
Principal
Dr. Klein is an Adjunct Professor of Pharmacology & Toxicology in the Brody School of Medicine at East Carolina University. In addition, he has been the founder of an SMO, CRO, Medical Writing Company, Analytic Lab, GI Biotherapeutics company, and a physician consulting company.
About Global Life Sciences Alliance (GLSA)
GLSA’s Global Network of solutions providers incorporates a variety of CROs and specialty vendors to support the specific needs of your clinical trial. Our network includes full-service CROs, biometrics, site selection, patient recruitment and retention, clinical supply chain management, and more. GLSA pre-qualifies all members of our network so you can be comfortable working with quality service providers.
We connect Sponsors with the CRO that has the right experience, culture, and capabilities to execute their research protocol. We leverage our extensive experience and harness our key relationships to work for CROs. We can fill any gaps you need to support your client’s trials. GLSA takes the guesswork out of vendor selection with our industry experts and experience.
What are your challenges? Contact GLSA to learn more about how we can help you accelerate your speed to market.