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A Little About Our Company
In the small biotech world, budget is always a concern, but the success of a product is dependent on the high-priced clinical development programs.
Most companies choose to outsource clinical data activities to contract research organizations (CRO). A professional clinical data manager working on behalf of the sponsor company is critical to ensuring that all the required data per protocol is collected efficiently and accurately, but based on cost, companies cannot justify hiring a full-time employee for this role.
With a wide range of experience and superb problem-solving skills, Wagstaff Clinical Data Consulting serves as a trusted advisory partner for small biotech companies.
Wagstaff Clinical Data Consulting can step in at the beginning of the clinical development program or help companies in rescue situations as advisory engagement.
Services
Johanna advises clients across the full spectrum of clinical data management, including
Clinical data management from study start-up to database lock
Data management document creation and/or review
CRF design and database set-up
Data mining for ongoing trial maintenance
Standard Operating Procedures (SOP) for in-house and outsourced data management
Data listing and coding reviews
SAE reconciliation
Vendor evaluation and qualification
CDISC, 21SFRpart 11, E6R2 and EDC experience
Therapeutic Areas
Oncology
Pain
Anti-infective
Pulmonary Arterial Hypertension
Sleep Disorders
Congestive Heart Failure
And more...
President
Johanna Wagstaff
Johanna Wagstaff is a senior clinical data management advisor with more than 25 years of experience guiding pharmaceutical and biotechnology organizations through the full lifecycle of clinical trials — from study start-up through NDA submission.
As founder and President of Wagstaff Clinical Data Consulting, Inc., she serves as a trusted strategic partner to leadership teams navigating complex data management decisions. Her counsel has supported five Phase III programs through New Drug Application submissions, with a deep specialization in oncology and a broad background across multiple therapeutic indications.
Johanna advises organizations on optimizing data management infrastructure, vendor relationships, and CDISC-compliant processes that improve data quality and accelerate time to database lock. She brings both hands-on expertise and a strategic lens — helping teams build efficient, scalable data operations whether managed in-house or through CROs.
Areas of expertise include: database design and CRF development, CDISC standards, EDC systems, 21 CFR Part 11 compliance, SAE reconciliation, SOP development, vendor evaluation, and cross-functional team leadership.
Johanna holds a B.S. in Microbiology and Molecular Genetics from UCLA. Outside of work, she is an avid reader, crocheter, and active community volunteer.
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