BioPharm Systems has developed procedural documentation packages
to assist companies with establishing process standards in the
following areas: information technology operations, clinical data
management, clinical trial management, and product safety. Our
packages provide a basic set of standard operating procedures
(SOPs) and guidelines that define the technical and process
requirements for efficiently planning, preparing, and managing your
organization in the above areas.
Each SOP package includes:
- High-level policies and SOPs, which can be delivered in a
generic form or tailored to a particular clinical or safety
application
- Guidelines presented in a visual format, detailing how each
procedure is performed
- Forms and templates to support procedures and make it easier to
complete the data entry process
- Standards for critical functional areas
- Roles and responsibilities table defining who is responsible
for performing individual functions within each SOP and
guideline
- A slide presentation with instructions on how to customize the
documentation to best fit your company's specific needs
- Worksheets to customize the SOPs and guidelines to fit your
company's unique needs, and to help keep the system organized
Our SOP packages provide a proven framework for maintaining the
integrity of your data by keeping your clinical technology
solutions in compliance.
