About Nonclinical Development Assistance, LLC (N-cDA)
About Nonclinical Development Assistance, LLC (N-cDA)
Nonclinical Development Assistance (N-cDA) was founded in 2014 to assist with the operational needs of Preclinical Development in the Biopharmaceutical industry. N-cDA has over 25 years of biopharmaceutical drug development experience in academia, CROs, and private industry working with small molecules and biologics.
N-cDA incorporates its experience in the private sector, CROs, and academia to assist with the management of Preclinical Development including:
√ Preclinical Development Budget Management
√ CRO Relationship Building
√ Training of GLP and Study Managers
√ Building Cross-Functional Teams
√ Process Improvement
√ SOP Development
√ Archival Programs
Nonclinical Development Assistance offers PMI certified project management services (2013-2016). Additionally, Six Sigma certification allows N-cDA to be a powerhouse when preparing your preclinical programs for forward traction, specializing in:
√ Data Integrity Review for Modules 2 and 4
√ Generating Tabulated Summaries for NDAs
√ Working with Regulatory Operations
√ Documenting regulatory questions and responses from multiple agencies
√ Preparing and Publishing Safety Reports
√ Updating the clinicaltrial.gov website
√ Providing Project Management Expertise for GLP Inspection Readiness
√ Data Discovery
√ Preparing data for out-licensing
Nonclinical Development Assistance is a continuous force for study management conventions by oversight of review and quality control of nonclinical protocols through reporting and monitoring studies being conducted at CROs. Additionally, N-cDA’s ability to discuss and coordinate strategies with toxicologists allows N-cDA to prepare timelines for a multitude of programs making Nonclinical Development Assistance a formidable force for your preclinical programs.
Non-clinical Development Assistance (N-cDA) was founded in 2014 by Vicki Viana to assist with the operational needs of Preclinical Development in the Biopharmaceutical industry. Vicki Viana has over 25 years of biopharmaceutical drug development experience in positions within academia, CRO, and private industry working with small molecules and biologics.
Vicki’s career began in academia working at Northeastern University and at the USDA Human Nutrition Research Center at Tufts University. She then went on to the private sector at Oculon and joined the CRO Bio Development Laboratories (BDL) which is now part of CRL. After leaving CRL, Vicki expanded on her career in Preclinical Development at Biogen managing the Preclinical Study Management group. During her 15 years at Biogen, Vicki was responsible for the preclinical budget (encompassing Discovery Toxicology, Developmental Toxicology, DMPK, and Bioassay), training of GLP and study managers, CRO liaison, leading cross functional teams, numerous process improvements including SOP development and archiving.
Vicki earned her PMP Certification from the Project Management Institute in 2013 as well as earning the Six Sigma Green Belt. This new direction allowed Vicki to extend her career as a Life Sciences Project Management Consultant with Integrated Project Management (IPM) and finally on to Nonclinical Development Assistance (N-cDA).