Close

Edge Alliance

Edge Alliance is different. We are not trying to be different, we just are. Rather than developing an organization that makes its employees, consultants, or clients conform to our style or personality, we encourage people to be their unique selves; like a good meal, Cup of Joe or music riff. We take pride in the fact that our consultants are experts in their chosen discipline and in their ability to complete projects effectively and on time. We succeed based on the great work and results that our team produces.

EDGE ALLIANCE

Biotechnology and Pharmaceutical Consulting

Edge Alliance is a Biotechnology and Pharmaceutical consulting firm that brings an innovative approach to career development and program management. We support organizations throughout North America by providing outstanding professionals who specialize in Biotechnology and Pharmaceutical Clinical Studies.

Edge Alliance is a diverse group of professionals within clinical development consulting, which comes naturally when working in a Biotechnology and Pharmaceutical hotbed like the San Francisco Bay Area. We are particularly successful at providing specialized clinical regulatory, and drug safety consultants.

Innovation is an essential part of our offering and we are dedicated to making sure that your experience working with us reflects that. This means whether you are a consultant or a client, you will have our complete attention, your priorities will become ours, and you will be acknowledged for being an integral part of our business.

At Edge Alliance, we pride ourselves on the expertise of our team. We work with each client directly. We are candid because we believe in results. We don’t work in silos because we enjoy collaboration and teamwork especially when good music and a robust cup of coffee are involved. We bring something new and valuable to our consultants and clients with our experience and personalities.

Team Edge

MAURICE LITTLE

CHIEF EXECUTIVE OFFICER

DANIEL MCGOWAN

CHIEF FINANCIAL OFFICER

AIMEE PASCHKE

CHIEF OPERATING OFFICER

Our Clients

Finding the right professionals for your organization can be a time-consuming and stressful process, not to mention dedicating resources that may already be overwhelmed. So why not connect with a team of experts in this field?

We have proven, beneficial, and effective partnerships with many organizations.

We work closely with you to get a solid understanding of the projects impacting your teams and organization, and the professionals you need to facilitate success.

Our consultants go through a rigorous, multi-step interview process before being represented to your organization. Not only do we discuss your roles in detail, we also make sure that specific traits are noted to ensure your time is not wasted.

But we don’t stop there!

As our consultants are on project we have a Quality Assurance process that all but eliminates typical communication issues and project attrition. We also reward our consultants for their success because we believe they are the life-blood of Edge Alliance.

We provide a quick and effective service so that you can focus on your company’s success.

Medical Affairs
  • Medical Affairs
  • Medical Communication
  • Medical Information
  • Medical Science Liaison
Regulatory Affairs
  • Regulatory Operations
  • Regulatory Strategy
  • Regulatory Filing
  • Regulatory Liaison
  • CMC Specialist
Medical Writing
  • Medical Writer
  • Sr. Medical Writer
  • Associate Director of Medical Writing
  • Director of Medical Writing
Drug Safety
  • Intake Professional
  • Drug Safety Associate
  • Drug Safety Manager
  • Triage/QC
  • Drug Safety Scientist – MD
  • Drug Safety Operations Associate Director
  • Drug Safety Operations Director
Clinical Development
  • Clinical Scientist
  • Medical Monitor
  • Associate Director of Clinical Development
  • Director of Clinical Development
  • VP of Clinical Development
  • CMO
Biometrics
  • Biostatistician
  • Director of Biostatistics
  • SAS Programmer
  • Sr. SAS Programmer
  • Manager of SAS Programming
  • Clinical Data Coordinator (CDC)
  • Clinical Data Manager (CDM)
  • Director of Data Management
Clinical Operations
  • Study Coordinator
  • CTA
  • CRA
  • Sr. CRA
  • Clinical Trials Manager
  • Program Manager
  • Associate Director of Clinical Operations
  • Director of Clinical Operations
  • VP of Clinical Operations

Our Services

Edge Alliance prides itself on representing the best individuals for Pharmaceutical and Biotech roles across a variety of sectors. We accomplish this by leveraging market intelligence, our vast network of industry experts, and Key Opinion Leaders. We are dedicated to working with consultants who are not only qualified, but whose careers will be enhanced by the opportunities we provide for them. We take a 360 degree approach that provides both consultant and client with the best possible options.

Our exceptional service requires the Edge Alliance Team to have a clear understanding of emerging market trends and evolving industry challenges so that we can provide the greatest professionals in their chosen discipline.

Our clients come to us because they know that we will be responsive, flexible, and have everyone’s best interest at heart.

Consultants

It is important for us to create a meaningful experience for our consultants.

We emphasize the importance of life/work balance while making sure that you are surrounded by amazing individuals who challenge and inspire you to be the best in what you love to do.

Clinical Operations

Site Management, Site Qualification, PSSV, SIV, IMVS, Study Management, CRO, Vendor Screening, Budget Management, Source Document Development, Monitoring Reports, Site Monitoring, RFP, SOP Development, In-House Resource, Field Monitor, Phase I, Phase II, Phase III, Phase IV, CRF, eCRF, TMF, Clinical Material Supply, GCP, EDC, CTMS, Central Labs, PI Training, ICF, Inspection Readiness, Site Auditing, QA, Clinical Quality, Reference Manual, Sponsor Management, EDC

Clinical Development

Clinical Trial Design (implementation, analysis, and interpretation), Clinical Protocol Development, IB Development, Phase I, Phase II, Phase III, Phase IV, Strategic Planning, FDA Negotiations, KOL development, PI Development

Medical Affairs

Phase IV, Study Protocols, Observational Studies, Publication Planning, Brand development, Sales Training Material Development, SOP development, Medical Guidance, Medical Response Letters, Medical Review, Pre-Launch Medical Information, Specialty Pharmacy, Medical Training, Managed Care, Formulary Dossiers, Medical Research and Analysis, Posters, Publications, Reference Manager, Electronic Health Records (HER), HOER, AMA, Off Label Analysis, Literature Search, (RPMS) Resource Patient Management Systems

Drug Safety

Intake, Case Management, Narrative Writing, Medical Coding, MEDRA, WHODD, Medical Review, Medical Assessment, Signal Detection, Causality, Expectedness, MedWatch, REMS, Argus, ARISg, PSUR, DSUR, Work Flow Development, AE, SAE

Medical Writing

IND, NDA, BLA, IB, Protocols, CSR’s, Narratives, Manuscripts, PSUR, Informed Consent, CTA’s, sNDA’s, Annual Reports, AMA

Regulatory Affairs

eCTD, Publishing, eCTDXpress, CMC, Regulatory Filing, FDA, ICH, IND, NDA, BLA, Clinical Quality, Audits, FDA interactions

Biometrics

Clinical Study Design and Reporting, Statistical Analysis Reporting, ISS, ISE, SAS Programming, Generation of Tables/Listings/Figures/Graphs, Statistical Sections of Protocols, Epidemiology, Statistical Analysis Plan (SAP), CDISC, TLFs, TLGs, SDTM, CRO Oversight, Validation of Data, Master Analysis Plan, Data Cleaning, Algorithms Development, Data Managment, Data Closeout, Data Base Lock, CRT, and EDC

Contact Us

Call (408) 800-4011 today to discuss how we can support you and your team, so you can Grow with Us!

We LOVE having visitors, come see us at:
1475 S Bascom Ave
Suite 218
Campbell, CA 95008

Need help finding us?