Clinical Trial Management of Product Development Sponsored Program

Pacesetter was the lead contract study manager for a:

•  Hepatology global clinical trial for a pharmaceutical company 

•  Developing pipeline molecules in the area of non-alcoholic steatohepatitis (NASH), a type of non-alcoholic fatty liver disease (NAFLD)

Cooperative Group and Academic Network development in both the United States and Europe to help these trialists to prospectively deliver registration studies

Pacesetter acted as an internal consultant for cooperative groups:

• observed and evaluated top US cooperative group conducting trials in breast cancer

• assessed cooperative group systems, hiring, and processes and compared them to pharma for line extension trials

• provided senior cooperative group leadership feedback re: the differences in standards, systems, standards, and processes in a written report and presentation for line extension trials

• assisted cooperative group in developing global engagement plan to increase member footprint in China

• lead budget development efforts for US, EU, and Asia-Pac via an inclusive global approach directed towards a line extension trial

Landscape Analysis of Cooperative Groups in Oncology

Pacesetter provided a landscape assessment of:

• Oncology cooperative groups conducting Ph. I-IV clinical trials for a top 5 pharmaceutical company

• Identifying cooperative group's disease committees, study management capabilities, ongoing or published study results, and relevant contacts

Cooperative Group Working Models for work with Chinese Investigative Sites

Pacesetter developed a model and roadmap for:

• infrastructure and development of a Chinese cooperative group in oncology

• including hiring plan, job descriptions, overall budget, and timeline required to develop this model in China

Guidance document creation for companies to augment working models with external collaborators in alignment with their own SOPs and preferred systems/processes

Pacesetter drafted guidance documents for cooperative groups to perform line extension trials for pharma and improved the mutual understanding of requirements for supplemental indication filings.

Guidance documents included feedback from pharma product development, functional experts, and medical affair's staff, including:

• Clinical Science

• Clinical Operations

• Safety

• Data Management

• Statistics

• Quality

• Legal

• Regulatory Affairs