Issue of a Certificate of Accreditation for a Center of Clinical Studies or Bioequivalence

Required Documents

• The following documents are required, according to each stage in the service:

• Phase I (at the Center):
  • Application form.

  • Latest inspection report issued by competent authority (if any).

  • Notarized Copy of the operating license issued by the competent authority in the country of origin.

  • Copy of the Contract(s) of Leasing of the Clinical Unit and of the Rendering of Services of Laboratory Analysis (if applicable).

  • Training schedule for employees.

  • Curricula of the main researchers and the persons responsible for the clinical, analytical and statistical stages.

  • List of SOP’s , and 5 SOP’s from the above mentioned should be provided.

  • Organizational chart of the center and the study plan.

  • Background of the Bio equivalence Center (Site, Master file), including total number of studies conducted and list of those submitted to other health authorities.

  • Notarized copy of accreditation certificates.

• Clinical Phase:
  • Notarized copy of the operating license issued by the competent authority in the country of origin (in case of outsourcing).

  • Staff training schedule.

  • List of the equipment and instruments used.

  • The following SOPs: collecting samples , emergency care of subjects, hospitalization of subjects, cleaning and preparation of areas for hospitalization of subjects.

• Clinical Laboratory Analysis Stage:
  • Notarized copy of the operating license issued by the competent authority in the country of origin (in case of outsourcing).

  • Staff training schedule.

  • List of the equipment and instruments used.

  • List of technicians in the area with the technical qualifications for each professional.

  • Models of the control file / control records used ( temperature of the refrigerators, freezes, room temperature, room humidity, calibration of pipettes, reagents and standards).

  • Bio-safety programs.

• Analysis Phase:
  • Notarized copy of the operating license issued by the competent authority in the country of origin (in case of outsourcing).

  • Staff training schedule.

  • List of the equipment and instruments used.

  • List of area technicians with technical qualifications for each professional.

  • Models of the control file / control records used ( temperature of the refrigerators, freezes, room temperature, room humidity, calibration of pipettes, reagents and standards).

• Statistics Stage:
  • Standards Operation Procedures, contemplating of the following points:

  • a. Data entry ((tabulation, verification of transcript data, software used).

  • b. Data processing and statistical analysis (methods of calculating pharmacokinetic parameter methods to identify factors to define the outliers, variance analysis, confidence interval calculation and program used).

  • Proof of contract between the bio-equivalence center and the person in charge of statistics (in case of outsourcing).