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1. About Aisimo (Love Smomed)
1.1 Company profile
Beijing Aisimo Medical Science and Technology Co., Ltd. is a professional service institution that assists clinical trial institutions with site management and specific operations in clinical centers, i.e., a Site Management Organization (SMO) for clinical trial.
Under the guidance of investigator, Clinical Research Coordinator (CRC) is responsible for routine work not associated with medical judgment in clinical trials and is the participant and coordinator of the whole experiment. CRC provides detailed support for various aspects, enhances clinical trial site management, improves clinical trial quality and progress, and promotes standardized process of clinical trials.
Beijing Aisimo Medical Science and Technology Co., Ltd. was founded in 2007 and there are almost 100 CRC employees with a background of nursing, pharmacy, or clinical medicine at present. Aisimo covers more than 20 important cities and 300 departments in china and has established international standard operating procedures (SOPs).
1.2 Corporate Culture
Company vision: strategy of success through quality and become the leader in clinical trial site management
Company mission: to serve for medical and pharmaceutical research and devote itself to human health
Core values: integrity, rigorousness, and excellence
Operation principles: respect and cultivate employees, provide standard, high-quality, and highly efficient clinical trial service, and provide value-added service to customers.
1.3 Our team
There are almost 100 employees in our CRC team with a background of nursing, medical science, and pharmacy and they have English certificates above CET-4. Most of them have experience in nursing and are familiar with hospital environment, working process, and investigators’ communication habits.
CRC team members have solid professional knowledge and are familiar with ICH-GCP, GCP, and related laws and regulations. They have also received well trainings on SOP, CRC professional skills, and soft skills. 80% employees have working experience in international multicenter clinical trials and clinical trials conducted by famous enterprises in China and have rich experience in project management. They are familiar with Electronic Data Capture (EDC) System and drug interactive voice/web response systems (IV/WRS), such as Inform, Rave, and RDC.
Project management (PM) team has rich experience in international multicenter clinical trials, CRC experience for more than 5 years, and management experience for more than 2 years.
Aisimo offers profect training system. An excellent profession team provides systematic training to improve employees’ competence and professional skills and ensure service quality. The training includes basic training, professional skill training, project training, and advanced training etc.
1.4 Our advantages
We can accurately learn customer needs and provide high-quality service and solutions to customers;
We have rich experience in project management and cover multiple clinical research centers;
We are equipped with a perfect SOP system, training system, and quality assurance system;
We have a professional and competent medical team and strictly control project analysis, training, and guidance;
We implement the humane management, respect employees’ sustainable career development, and thus have strong team stability.
2. Scope of services
2.1 Business scope
Aisimo’s business scope covers all phases of clinical trials and therapeutic fields include tumor, cardiovascular system, endocrine, respiration, anti-infection, mental state, nervous system, nutrition and medical devices etc. With the help of service concepts of professionalism, pragmaticality, and integrity and perfect training and management systems, Aisimo has created various cooperation models with the Chinese characteristics, accumulated rich source of clinical research institutions, obtained customers’ recognition and praise, and established a good reputation in this industry.
2.2 Service content
2.2.1 CRC Service
Preparation for trial
1. Feasibility investigation for research centers;
2. Cost and budget management;
3. Contact with Independent Ethics Committee (IEC) and assist investigators in preparing and submitting ethics files;
4. Prepare project launch meeting and conduct meeting management;
5. Coordinate with and provide training to research institutions, Department of Pharmacy, Department of Clinical Laboratory, and investigators;
6. Contact with the sponsor/CRO.
Implementation of trial
1. Manage subject recruitment;
2. Manage subject visits;
3. Manage study files and folders;
4. Manage investigational drugs and test materials;
5. Manage laboratory samples and auxiliary examinations;
6. Assist in report and tracking of safety information;
7. Input data and help investigators to answer questions;
8. Conduct ethical communication and submit related files;
9. Cooperate with monitoring, audits, and inspections;
10. Others, for example, financial management etc.
End of trial
1. Assist in data cleaning;
2. Make an inventory of investigational drugs and materials and conduct recycling;
3. Collect and manage bills;
4. Organize project files and put them in archive.
2.2.2 Quality control service
Assist the sponsor in data auditing
Assist the research institution in quality control
2.3 Service mode
The mode of CRC project director +CRC project manager +CRC lays a solid foundation for providing high-quality service to customers. We will design specific service management plans for each project according to the service mode of project management, including schedule management, quality management, personnel management, communication plan, and risk management etc.
2.4 Service procedure