As the selected customer, CRO can generally provide the following professional services for the applicant:
1, acting as an agent for drug registration application and clinical trial approval.
2. Translation and preparation of application materials.
3. Draft and improve the test plan.
4. Selection of researchers and participating units.
5. Provide or select a central laboratory.
6. Develop standard operating procedures.
7. Study the blind packaging of drugs.
8. Multicenter randomization and management.
9. Design of case report form.
10, compilation of the researcher's handbook.
1 1, test progress and organization and coordination.
12, test and drug safety report.
13, test data processing and statistical analysis.
14, quality control and quality assurance.
15, write a summary report of clinical trials.
Second, how to choose CRO company
1, specialization advantage
A mature CRO should have the following professional advantages.
(1) Be familiar with the government's drug management regulations and implementation rules.
② Understand the international practice and guiding principles of drug clinical trials.
③ Experience in multidisciplinary drug clinical trials.
④ Select the combination of researchers and make an effective and feasible experimental scheme.
⑤ Organize and implement clinical trials according to international standard operating procedures.
⑥ Implement quality control and quality assurance in clinical trials.
⑦ Data processing and statistical analysis of clinical trial results.
(8) Draft the summary report of clinical trial according to the instruction.
In the process of developing a new drug, 70% of the cost and 2/3 of the time are usually used for clinical trials. Therefore, how to reduce avoidable mistakes and obtain high-quality research results in the shortest time is a problem that applicants need to make careful decisions when designing clinical trials of new drugs. By making full use of the above professional advantages of CRO, applicants can get twice the result with half the effort.
2, pay attention to the elements
When selecting CRO, the applicant should conduct necessary audit to confirm his ability to complete the entrusted work or whether he is qualified to undertake corresponding responsibilities. The audit can focus on the following aspects.
(1) Past performance and contract performance ability.
② Previous customer evaluation and satisfaction.
③ The internal organizational management structure of the enterprise.
④ Quality level and stability of employees.
⑤ Procedures and records of employee training.
⑥ Specialized experience in a specific field.
All landowners standardized operating procedures (SOP).
⑧ Necessary equipment and facilities.
Pet-name ruby data security and confidentiality measures.
3, check the content
During the execution of the contract, the work can also be inspected according to the time and procedures agreed in advance or temporarily. The main contents of verification are:
(1) Work of the project leader and main participants.
② Training for all personnel, including researchers.
③ Formulate and implement standard operating procedures (SOP).
(4) Implement the revised test plan or informed consent.
(5) all serious adverse events's records and reports.
⑥ Information exchange with applicants and researchers.
⑦ Progress of research plan and problems to be solved.
(8) To study the management and preservation of drugs.
Pet-name ruby file management and preservation.