websteed.com

versanteintl.com

Versante International, LLC - Biometrics Services

http://www.versanteintl.com/web-files/data_management.htm

Versante provides comprehensive data management services for Phase I-II clinical trials. Our qualified team of Statisticians, CRF Designers, Database Programmers and Data Managers all work together in developing the Data Management Plan specific to your trial. We have experience in working with paper-based data collection methods as well as with electronic data capture (EDC) systems. Data Management Services Include:. Case Report Form (CRF and eCRF) design. Development of Data Management Plans.

versanteintl.com

Versante International, LLC - Biometrics Services

http://www.versanteintl.com/web-files/careers.htm

Versante offers career opportunities in a variety of areas in the clinical development process, with an emphasis on:. EDC and Data Management. We offer competitive salary, excellent benefits and a non-smoking environment. Versante is an Equal Opportunity Employer. If you would like to be considered for a position, please send a cover letter, your resume/CV with salary history to:. Versante International, LLC. 1200 Lakeshore Ave, Suite 16D,. Oakland, CA 94606. Email to hr@versanteintl.com.

versanteintl.com

Versante International, LLC - Biometrics Services

http://www.versanteintl.com/web-files/CDISC.htm

Clinical Data Interchange Standards Consortium (CDISC, http:/ www.cdisc.org. Is an open, multidisciplinary, non-profit organization committed to the development of worldwide standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. The CDISC SDTM (Study Data Tabulation Model) was designed to improve communications between sponsor organizations and regulatory authorities.

versanteintl.com

Versante International, LLC - Biometrics Services

http://www.versanteintl.com/web-files/news.htm

Statistical Analysis and Reporting. Protocol Development and Study Design. Electronic Data Capture (EDC).

versanteintl.com

Versante International, LLC - Biometrics Services

http://www.versanteintl.com/web-files/about.htm

Versante serves as your expert virtual Biometrics Department, with a focus on providing innovative study designs to overcome complex challenges created by conflicting regulatory, marketing, medical and statistical needs, Versante is fully committed to delivering exceptional value to their clients. Optimizing clinical development plans that address complex challenges presented by conflicting regulatory, marketing, medical and statistical needs. Our Clients benefit from:. Statistical Analysis and Reporting.

versanteintl.com

Versante International, LLC - Biometrics Services

http://www.versanteintl.com/web-files/our_success.htm

Our successes include, but are not limited to the following:. Client #1 – Late Phase Program in Melanoma. Versante was commissioned to validate the results of the analysis conducted by the company’s pharmaceutical partner. The clinical study data was transferred to Versante for review and re-analysis. Versante served as the company’s Biometrics Department. Re-analyzed the prior melanoma data obtained from the Pharmaceutical Partner who initially conducted the analysis. Versante served as the company&rsqu...

versanteintl.com

Versante International, LLC - Biometrics Services

http://www.versanteintl.com/web-files/leadership.htm

Dr Verjee is the founder of Versante. He is a biostatistician with over 30 years of pharmaceutical and biotechnology industry experience. His passion is in coming up with solutions to problems that seem intractable. He is focused on assisting companies with NDA and BLA submissions, streamlining data-related operations and optimizing clinical development plans and study designs. Statistical Analysis and Reporting. Protocol Development and Study Design. Electronic Data Capture (EDC).

versanteintl.com

Versante International, LLC - Biometrics Services

http://www.versanteintl.com/web-files/edc.htm

All data management processes at Versante adhere to Good Clinical Practices (GCP) and meet 21CFR 11 compliance requirements. Statistical Analysis and Reporting. Protocol Development and Study Design. Electronic Data Capture (EDC).

versanteintl.com

Versante International, LLC - Biometrics Services

http://www.versanteintl.com/web-files/proven_success.htm

Versante has successfully contributed to BLA and NDA submissions including successfully supporting a client with resolution of their complete response letter from the FDA. Statistical Analysis and Reporting. Protocol Development and Study Design. Electronic Data Capture (EDC).