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 offers a cost-effective solution 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.

Services

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

Ms. Wagstaff is a senior-level clinical data manager consultant and the President of Wagstaff Clinical Data Consulting. She has 23+ years of experience executing all phases of clinical trials, including five phase III products supporting New Drug Application submissions. She has experience as a cross-functional team leader, managing both in-house data management and Clinical Research Organizations, with an emphasis on adapting and incorporating new processes that improve data quality and reduce time to database lock. She specializes in oncology, along with numerous other indications. She has extensive experience with database design, data review through the final CDISC datasets. She has a Bachelor of Science in Microbiology and Molecular Genetics from the University of California, Los Angeles (UCLA). As the president of Wagstaff Data Consulting, Ms. Wagstaff works with all her clients to ensure the data collection is an efficient fit for the program.

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