Practice Help

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Helping Your Practice Maneuver Through Clinical Trials

Unlike other clinical trials support companies that just provide help with training or site assistance, Sephmer provides all-in-one.

Investigator Team Training

Sephmer Sciences has therefore become one of the first international “investigator development organization” (IDO), meaning, we are a clinical trials organization focused on the development of investigators and clinical research programs (in academic institutions, private practices, community hospitals, and industry). Therefore, we focus on teams (Principal Investigator, Study Coordinator, and Research Nurse - may also include a Sub-Investigator). Everyone is trained and capable of doing their part, with Sephmer's model!

Sephmer Helps with Clinical Management: New Investigators and Sites

Clinical management includes:
  • Study budget
  • Informed consent process
  • Study participant recruitment
  • Monitoring
  • Completing a case report form
  • IRB submission
  • Roles of pharmacy, radiology, and clinical laboratories

Site Management Assistance

Sephmer helps sites with not only training but, identifying research studies (sponsors looking for investigators and sites) through our liasion services. We also help with preparing for the study by assisting with identifying current site resources (IRB, pharmacy, labs, diagnostics, etc.) and needs. Sephmer helps prepare investigator teams to manage the needs of the trial (i.e., recruitment, CRF completion, reporting requirements). We not only train you but help you transition to become an investigator.

Key Individuals in Clinical Research

Principal Investigator, Co-Investigators, Central Laboratory, Medical or Treatment Facility, and all other relevant individuals that must participate in a clinical trials is included on the Form 1572.

 

Removing the Mystery: What is the Research Investigator Responsible For?

An investigator has the following obligations or tasks:
  1. Statement of the education and experience which qualify him or her to perform the study.
  2. IRB will be responsible for the initial and continuing review and approval of the study.
  3. Proper and secure storage of the investigational agents and maintain adequate agent accountability records (Section 15).
  4. Required to prepare and maintain adequate and accurate case histories (Section 10).
  5. Submit (accurate) data to the sponsor.
  6. Promptly reporting any Adverse Events. 
  7. Following the study protocol.

Helping with Your Research Responsiblities

 
All clinical trials/studies occurring after 1997 are expected and required to follow ICH GCP.
 
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Sephmer focuses on assisting phyisicans meet the ethical standards of GCP, sponsor requirements, and patient participant needs.