Services Include but not limited to:
  • Project Management
  • Product Development
  • Clinical Research & Development
  • Designing and implementing Strategies
  • Medical Affairs and MSL
  • Medical Education
  • Regulatory Affairs
  • FDA Presentations and Communications
  • Marketing New Products
  • Post Marketing Indications and Strategies

Project Management:
  • Managing multiple  clinical studies.
  • Extensive experience in IND and NDA filing and submissions.
  • Designing and Implementing project management studies.​
  • ​Leading successful and incredibly detailed project management team and department.
  • Negotiating the study budget with sponsers and our clients to insure maintaining clinical trial within  client budgets.
  • Training project management team on how to apply new strategies, new effective technologies, and clinical protocols.

Clinical Research & Development:
  • Designing and implementing clinical trial in all phases I-IV.
  • Designing, writing, and developing clinical protocols for every phase I-IV.
  • Recruiting patients, sites, and investigators for every clinical study.
  • Requesting and attending investigator meetings to insure trials running effectively.
  • CRA's training and monitoring both in-house and on-site.
  • ​Implementing GCP guidelines and FDA regulations.
  • CRO selection and contract negotiations.
  • Designing and interpreting Case Report Forms (CRFs).
  • Negotiating study design and study cost with our clients and their sponsers.
  • Writing and editing final study reports for all phases I-IV annualy and semi-annually.
  • Discussing final study reports with the FDA.
  • Writing and editing Informed Consent Forms for study patients.
  • Initiating and conducting new services for biotechnology and pharmaceutical companies.
  • Liaison with other corporations when working with other licensing agreements.
  • Designing and conducting major and all scientific international presentations.
  • Significant experience in designing and conducting clinical trials using highly sensitive procedures in molecular markers.
  • Monitoring and supervising multiple study sites nationwide and internationally.
  • Insuring data availability and confidentiality.

Medical Affairs:
  • Medical writing and editing.
  • Medical science liaison.
  • Biostatistics.

Regulatory Affairs:
  • IND and NDA filing and submissions.
  • Frequent reporting to the Food and drug Administration (FDA).
  • Editing, interpreting, and reporting final study reports.
  • Insuring effective collaboration with other departments in the company.
  • initiating and conducting pre-IND meetings.​

Product Development:
  • Design and create product development plans.
  • Design the company's product development strategies.

Drug Design and Development....More

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