You Deserve Effective, Quality Clinical Trials. For 20 years, We've Delivered
Your BioPharma Therapies to Market Faster with Our Consulting Services
- Clinical Development: We analyze problems. Develop best fixes for you. Implement fixes. See more on Services.
- Quality Assurance/Compliance: We set up clinical quality functions. We act as scientific advisors on trials. We fix compliance & quality issues. We analyze & strategize on risk. We structure R&D operations for compliance. We train your team on good quality assurance & compliance. We innovate compliant clinical trial solutions. See more on Services.
- Go-to-Market: We provide strategic market assessments. We develop clinical portions of NDA/BLA for marketing approval. See more on Services.
Industries We Work In:
Biopharmaceutical, Biotechnology, Pharmaceutical, Digital Therapy, Medtech, Health Tech, Venture Capital
Business Functions We Work With:
Alliance, Business Development, Clinical Operations, Clinical Development, Compliance, Digital, Innovation, Quality Assurance, Quality Compliance, R&D Development or Operations, Regulatory, Risk Management, Strategy
Therapeutic Areas We've Worked In:
Allergy, anemia, autoimmune, hematology, immunology, immuno-oncology, immunotherapy, infectious diseases, cardiovascular, CNS, diabetes, digital health, neurology, neuroscience, neutropenia, oncology, osteoporosis, rare diseases, vaccines, viral, virology
Biopharmaceutical, Biotechnology, Pharmaceutical, Digital Therapy, Medtech, Health Tech, Venture Capital
Business Functions We Work With:
Alliance, Business Development, Clinical Operations, Clinical Development, Compliance, Digital, Innovation, Quality Assurance, Quality Compliance, R&D Development or Operations, Regulatory, Risk Management, Strategy
Therapeutic Areas We've Worked In:
Allergy, anemia, autoimmune, hematology, immunology, immuno-oncology, immunotherapy, infectious diseases, cardiovascular, CNS, diabetes, digital health, neurology, neuroscience, neutropenia, oncology, osteoporosis, rare diseases, vaccines, viral, virology
Trusted & Proven: Real Life Examples of Our Solutions for BioPharma Firms
A clinical stage Boston biotech firm was in a Phase 3 trial and needed to complete the trial & assemble data fast. We cut standard submission time by 75%. With HBP on the small submission team we created a clear, compelling, compliant submission & got approved in record time. Our client got their first product, an oncology therapy, earlier than expected, generating $6.4 million in revenue and shifting a Wall Street analyst rating to Buy because we were a key member on the NDA submission team. More cases on Services.
|
A Japan-based global pharma firm had overlapping R&D functions & siloed global teams leading to wasted effort. HBP was hired to optimize R&D clinical development processes, helping teams & functions tightly align with lean, clear, global SOPs that cut red tape processes in half, so their staff could focus on therapy approvals and product launch. Our client launched their metastatic breast cancer therapy in record time, achieving a key part of their 5-year plan. More cases on Services.
|
Find out the most common causes of clinical trial problems based on our 20 years working with elite biopharma firms. You can find out what problems to avoid and solutions by requesting our top problems list.
Are you skilled at emotional sensitivity in negotiating complex decisions needed to solve challenges like partner alliances or agreeing on scope between functional heads? You can find out by requesting our quiz & taking it.
Learn about the impact of the economy on the biopharma industry and how risk management can help by watching this video of Dr. Hughes, a certified Risk Management Professional & CEO Hughes BioPharma.
Hire HBP Today:
1) Click Button for Pre-Project Call. Fill Out & Submit This Form.
2) We'll Email You.
3) You'll Have a Call with Us to Discuss Your BioPharma Custom Services Price Quote.
1) Click Button for Pre-Project Call. Fill Out & Submit This Form.
2) We'll Email You.
3) You'll Have a Call with Us to Discuss Your BioPharma Custom Services Price Quote.
Supporting women in healthcare, biotechnology & pharmaceutical firms: Dr. Hughes volunteers as Board Member, Global Deputy Chair with Healthcare Business Women's Association leadership. We're a certified Women Owned Business.
Dr. Hughes supports women's health for 50up women through Living Loud Living Long. Listen to our podcasts on menopause, women entrepreneurs & healthy aging for women leaders.
Dr. Hughes supports women's health for 50up women through Living Loud Living Long. Listen to our podcasts on menopause, women entrepreneurs & healthy aging for women leaders.
Terms of Service: By using or accessing the Hughes BioPharma Advisers LLC website, or any other products or services, you are indicating you agree to our terms of service. If you do not agree to these terms, do not access or use our products or services. We may collect information about your or your use of this site. The information collected depends on what information you provide to us (for example, if you fill out a form on our product or service, we will receive this information and use it for the purpose specified on the form or form description). Our website and other services or products will collect access and use information. The purpose of our information collection is to improve our products and services and for marketing.
Hughes BioPharma Advisers LLC retains all copyright worldwide to our content, products and services.
By using or accessing the Hughes BioPharma Advisers LLC website, or any other of our products and services you indicate that you agree to our Data Protection and Privacy Policy; if you do not agree to this policy, do not use our website, podcast or products and services. Our data collection is described above in our Terms of Service. We work with third party service providers such as Zoom, Facebook or HostGator. These third party service providers may collect information on your use of our products and services. Information may include logins, cookies and other tracking of access and use. We use this information to improve our products and services and for marketing or for customer support.
Not Medical Advice: Hughes BioPharma Advisers LLC does not offer medical advice or treatment. Consult your physician for medical concerns.
Hughes BioPharma Advisers LLC retains all copyright worldwide to our content, products and services.
By using or accessing the Hughes BioPharma Advisers LLC website, or any other of our products and services you indicate that you agree to our Data Protection and Privacy Policy; if you do not agree to this policy, do not use our website, podcast or products and services. Our data collection is described above in our Terms of Service. We work with third party service providers such as Zoom, Facebook or HostGator. These third party service providers may collect information on your use of our products and services. Information may include logins, cookies and other tracking of access and use. We use this information to improve our products and services and for marketing or for customer support.
Not Medical Advice: Hughes BioPharma Advisers LLC does not offer medical advice or treatment. Consult your physician for medical concerns.