Services Include but not limited to:
- Clinical Research & Development
- Designing and implementing Strategies
- FDA Presentations and Communications
- Post Marketing Indications and Strategies
- 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 writing and editing.
- 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.
- Design and create product development plans.
- Design the company's product development strategies.
Drug Design and Development....More