Elevate Clinical
Consulting

Expertly managing your clinical
operations with speed & precision

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services

Elevate Clinical Consulting is your access to solutions for expert assistance with operational leadership, vendor selection and management, strategic support, study design and more. 
  • Worldwide leadership experience managing Phase I through Phase IV clinical trials from start-up through regulatory submission

  • Extensive experience selecting and overseeing the best Contract Research Organization aiding clients through the selection process from kick-off through study execution.

  • CRO and vendor management

  • Protocol synopsis and full protocol development

  • Standard Operating Procedure development, ensuring content is “right-sized” for the client

  • Gap analysis and staffing assessments to ensure your growing team is hired at the right time

  • Staff mentorship and guidance for team members

  • Strategic decision making

  • GCP Quality Assurance efforts and Inspection Readiness

about

Keri Urwin, CEO of Elevate Clinical Consulting, brings 25 years of proven expertise in Clinical Operations, guiding a diverse clientele from solo start-ups to global teams. Based out of Raleigh, NC, Keri is not only a devoted mom but also a leader who navigates the world with clear intent and purpose.

Keri excels at quickly resolving issues, uniting vendors and cross-functional teams to drive efficiency and results. Her leadership ensures streamlined timelines, effective problem-solving strategies, and the creation of strong, lasting relationships. When Keri is on the team, everyone is supported, and operations run smoothly – even in the face of obstacles.

Neurology

  • Multiple Sclerosis
  • Restless Leg Syndrome
  • Pain Management
  • Pulmonary Embolism/DVT
  • Diabetic Peripheral Neuropathy
  • Deep Vein Thrombosis

Metabolic / Endocrine Disease

  • Hyperoxaluria
  • Hypoparathyroidism
  • Phenylketonuria

Cardiovascular / Renal Disease

  • Congestive Heart Failure
  • Focal Segmental Glomerulosclerosis / MCD / Diabetic Nephropathy

Psychedelics / Psychiatry

  • Major Depressive Disorder

Hematology / Oncology

  • Solid tumors
  • Myelofibrosis
  • Bladder Cancer

Other

  • Food Allergy
  • Opioid Use Disorder
  • Medical Devices

Gastrointestinal Disease

  • Ulcerative Colitis

Sexual Dysfunction

  • Female Sexual Dysfunction

Gene Therapy

  • Phenylketonuria
  • Duchenne Muscular Dystrophy
Keri has successfully supported both large pharma companies and small biotechs. Known for her hands-on approach and strong work ethic, she ensures that team members are empowered and relationships are optimized, leading to greater efficiencies and successful outcomes.

testimonials

Keri is responsive, takes the initiative in collaborating with CROs, and is an absolute pleasure to work with!
Jeb Berelman
Director of Microbiology

Without Keri we would have never completed our trial! Keri was instrumental in navigating the operations of a very complicated clinical trial that was investigating a novel drug modality for the first time in humans.

Lee Swem
Chief Development Officer
Keri is superb. In a short amount of time, she organized our clinical operations strategy and plan and instituted initiatives to get enrollment on track and ensure data integrity. On top of that, she’s a joy to work with!

Chris Morabito, M.D

Chief Medical Officer
Keri is uniquely capable and deftly handles the routine and multifactorial aspects of clinical trial operations. Where needed, Keri draws upon her experience bank to adroitly handle the complexities that often present in order to make the puzzle pieces fit.
Chris Toombs
Chief Scientific Officer

contact

Contact us to hear more about how we can help support your Clinical Operations activities.

Keri Urwin, MBA

919-247-8845

919-247-8845

kurwin@elevateclinicalconsulting.com

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