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Edge Alliance

Alliance is different. We are not trying to be different, we just are. We decided that rather than developing an organization that make its employees, consultants, or clients conform to our style or personality; like a good meal, Cup of Joe or music riff, we encourage people to be their unique selves. Being experts at their chosen discipline and completing projects effectively is our drive. We succeed based on our team and the great work and results we produce.

EDGE ALLIANCE

Biotechnology and Pharmaceutical Consulting

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

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 in providing specialized clinical 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 have become ours, and will you 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 OPERATIONS 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 Associate
  • Regulatory Operations
  • 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 in representing the best individuals for Pharmaceutical and Biotech roles across a variety of sectors. We accomplish this by leveraging market intelligence and 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 Development

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

Clinical Operations

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, PubMed

Drug Safety

Intake, Case Management, Narrative Writing, Medical Coding, MEDRA, WHODD, Medical Review, Medical Assessment, Signal Detection, Causality, Expectedness, MedWatch, REMS, Argus, ARISg, PSUR, 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, CRFR Development, AMA

Regulatory Affairs

eCTD, Publishing, eCTDXpress, CMC, Regulatory Filing, FDA, ICH, IND, NDA, BLA, Clinical Quality, Audits, ISI ToolBox, Docubridge, sharepoint, InDesign, Visio, FDA interactions,

Biometrics

Design and Reporting, Clinical Study, Statistician, ISS, SAS Programming, SAS data set, SAS R, SAS graphics, IML, Tables, Listings, Figures, Graphs, Analysis, Statistical sections of Protocols, epidemiology, macro program, Statistical Analysis Plan (SAP), CDISC, TLFs, TLGs, SDTM and ADAM Models, CRO Oversight, Validation of Data, UNIX, Master Analysis Plan, Data Cleaning, Algorithms Development, RECIST Criteria, MacDonald Criteria, Data Close out, Data Base Lock, CRT, EDC, Data

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

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