Industry research: What is the best development model for CRC/SMO?

With the continuous enhancement of drug innovation capabilities, the demand for clinical trials is rising significantly

However, some industry voices believe that SMO still needs to be improved in cooperation with institutions

From the "age of innocence" to the age of competition

CRC originated in Europe, America and Japan, especially in Japan

In China, SMO companies began to appear in the late 1990s and mushroomed after 2008

Domestic SMO companies can be roughly divided into three categories: SMOs with only a single CRC business; SMO companies or subsidiaries established by CROs alone; SMOs established by sponsors that operate independently

Zhang Lei, who served as the director of operations at the old club Hangzhou Simo, is now the general manager of SMO company Krit

She recalled that 10 years ago was the embryonic stage of SMO in China

Back then, the projects were not so innovative, and they were not nervous in terms of project time, PI resources, and patient resources.

From 2009 to 2014, SMO companies with more than 100 CRC employees were established one after another

2015 is a critical time point

"The institutional requirements are getting stricter," Zhang Lei said with a smile.

Since then, CRC and SMO have entered a stage of rapid development, and the industry scale and professional ability have been significantly improved.

CRC's Duties and Controversies

Judging from the long-term upward trend of new drug research and development in China, the number of CRCs will continue to grow (see the figure below)

Source: "Blue Book on China's CRC Industry"

According to the statistics of "CRC Home" and DIA, the number of cities covered by SMO and CRC teams in China from 2014 to 2019 was 61, 66, 117, 129, 159 and 179 respectively, with an increase of 8.

Source: "Blue Book on China's CRC Industry"

As CRCs grow in size, their responsibilities change as clinical trials evolve

The clinical trial industry also puts forward some requirements for CRC qualifications (see the figure below), and in view of the future development trend and importance of virtual clinical trials and remote clinical trials, CRC may also increase the skills to master and apply IT and digital knowledge

However, some aspects of the CRC's responsibilities are still controversial.
For example, it is easier for CRC to communicate and communicate with patients.
In the process, CRC can obtain a lot of relevant information about the subjects, but the measurement of vital signs helps researchers understand The links that should be completed by the investigator and the evaluation of the start and end time of adverse drug reactions should also be completed by the CRC in the actual operation process
.

Liu Yang, CEO of Linkstar, is also the object of this survey
.
He believes that only when the tasks and priorities of the work are clarified, the hospital and SMO will have a clear management method and perform their respective duties
.
Linkstar now has resident staff in more than 90% of the top three hospitals across the country
.

"CRC is the core of clinical trial operations.
For subjects, CRC is a communicator, for research teams, it is a liaison between different professional departments, and for sponsors, it is a coordinator.
It clearly defines its own responsibilities in the complicated work.
Only by working every day with an altruistic heart can we escort high-quality clinical trials
.
” said Song Qingchun, founder of Spring Medicine, a CRO company
.

Talent demand brings industry challenges

Zhao Xiaomin majored in nursing in college, and joined SMO as a CRC after graduation
.
She thought she would be able to perform more in the company, but what she didn't expect was that after being dispatched to the agency, she had neither a white coat nor a fixed job position.
To her dismay, there were fewer opportunities for promotion in the company
.
"Where is our tomorrow?" Xiaomin was very confused about the future
.

Xiaomin's mentality represents the psychological status of some CRC personnel
.

Song Qingchun also mentioned that the CRC's daily work place is in the research center, but the sense of team belonging, collective honor, and the recognition of researchers, sponsors and institutions is low, which reduces the CRC's sense of achievement in work, and also requires enterprises Increased focus on CRC
.

The GCP Center of Tianjin Blood Research Institute is mainly responsible for blood disease-related drug trial projects.
The cycle is usually long, and the biggest challenge it faces is the large fluidity of CRC
.
According to Liu Lijun, GCP Center of Tianjin Institute of Blood Research, the greater the liquidity of CRCs, the heavier the tasks that stable CRCs undertake, while the new CRCs undertake less work.
SMO companies have certain difficulties in allocating work reasonably
.

"I hope to strengthen communication, provide a good working environment, enhance the sense of belonging, and work together with SMO to stabilize the CRC team
.
" Liu Lijun said
.

Shen Yifeng, head of the Shanghai Mental Health Center's Drug Clinical Research Institute, told R&D clients that some good CRCs are often poached by other companies, or they leave the front line after being promoted by the company
.
He hopes that through the joint efforts of enterprises and institutions, the CRC can be relatively fixed
.

What are the difficulties faced by the CRC team? R&D Customer aggregated the responses from the 15 companies collected in the survey (see chart below)
.

From the interview results, the lack of excellent talents has had a certain impact on the quality of clinical trials, which is the biggest challenge
.

Respondents from a number of companies indicated that the company should put talent training as the top priority, and should have long-term development plans and a perfect promotion mechanism for CRC personnel; sign talent introduction strategic agreements with universities to ensure that team stability meets business development requirements , to achieve sustainable business development; retain talents, and refine personnel management; CRC and research doctors should be full-time, the company should have training, and the hospital should have management; the hospital should give CRC respect and encouragement, and work together to develop
.

Shoujia Company, a subsidiary of Rundong Medicine, has more than 400 CRC staff, covering more than 60 cities
.
Jiang Hai, the company's CEO, felt deeply that the number of institutions and customers that have cooperated with the company in recent years has increased year by year.
If there is no stable team, it is impossible to talk about good development
.
In Jiang Hai's view, "Old employees should be given better remuneration packages, excellent management talents should be promoted, and new employees should be given perfect training to help them grow rapidly
.
"

Ha Pengcheng, general manager of SMO's Sisbia China, said at several meetings with human resources in 2021 that the construction of clinical trial disciplines and the training of more practitioners are urgent, and the existing nursing, pharmacy, public health, and clinical majors urgently need to expand enrollment
.
There is no university in China that provides specialized training for CRC
.
"Even if we act now, it will take 4 to 5 years for CRC to enter the industry, and newcomers who have just joined SMO must receive at least 3 months of training before they can participate in clinical trials
.
"

She introduced two approaches: one is to add clinical research majors.
Chinese medical and pharmacy colleges and universities should design clinical research professional courses that are both suitable for China's national conditions and in line with international standards, and issue professional certificates similar to ACRP; the second is to call on the industry to use multiple channels.
Speak up and raise public and social awareness of clinical trials, and more students will choose medicine and health and future clinical trials majors
.

Institutional management of CRC

In addition to SMO companies, there is also an effort to be made in terms of team building as the CRC's resident workplace
.

Institutions can provide CRC with convenience in work and life and enhance its sense of belonging
.
The Drug Clinical Research Institute of Shanghai Sixth People's Hospital has provided a fixed office area and data storage space for the stationed CRC, such as setting up a CRC office in the institution or clinical department, and providing them with work cards, work clothes, meal cards, etc.
as much as possible.
increase their sense of belonging
.

"Although the situation of working on the corridor has occurred from time to time, we are trying to find a solution
.
" Cheng Xiao, director of the agency's office, said
.
Cheng Xiao was interviewed by R&D guests after the 5th R&D Guest Clinical Annual Meeting and ChinaTrials13 Summit Forum
.

For institutions with many projects, there will be multiple companies co-existing.
Zhao Jie, chairman of Beijing Tianyuyuan Medical Technology Development Co.
, Ltd.
, believes that “the institutions should be treated equally, so that every CRC can feel that they are part of the big family of institutions.
member
.
"

Secondly, the organization can also conduct regular training for the station CRC to improve its service ability
.
Song Qingchun believes that institutions should formulate CRC training plans every year, so that CRCs can master the work flow and requirements of the resident institutions, constantly improve themselves in the busy work, and understand the latest national policy guidelines and industry development trends
.

On a daily basis, in addition to superior inspections, sponsor monitoring and audits, institutions should establish and implement a full-process quality control system such as three-level real-time quality control to reduce the risk of errors
.
The three-level quality control not only enhances the team spirit, but also reduces the risk of CRC errors from the system, and truly achieves the high requirements and strict standards of the original data records emphasized by GCP in a timely, accurate, true and complete manner
.

Liu Lijun believes that although there are various methods to reduce the risk of errors, according to GCP regulations, the main responsible persons of clinical trials are the sponsor and investigator, who are controlled by various links, not only relying on one CRC, and should try their best to strengthen training and communication.
Reduce the chance of CRC error, but the most important thing is that researchers and monitors should be careful
.

The SMO companies participating in the survey believe that organizations can take flexible assessment measures to enhance the vitality of the team
.
For example, the performance of CRC is directly linked to the priority level of SMO companies based on score assessment; institutions and SMO companies form a linkage, and at the end of the year, based on the performance of employees of each SMO company, the outstanding SMO and the best CRC will be selected
.

The researcher learned that in a tumor hospital in Zhengzhou, Henan, the CRC was scored by the hospital's clinical trial management department, ethics office, and researchers
.
CRCs with no previous experience in clinical trial projects can undertake clinical trials only if they have experienced CRC teaching for 2 months and pass the institutional examination and interview
.
There are also cancer hospitals that can undertake clinical trials after passing the CRC examination interview with more than 6 months of work experience or more than 1 year of work experience
.

The future of SMO

Ren Ke of Shanghai Jinshi Pharmaceutical Technology Co.
, Ltd.
and Gao Zhigang of Beijing CDH Stron Pharmaceutical Research Co.
, Ltd.
mentioned in the "Blue Book of China's CRC Industry" (October 2020) jointly published by China CRC Home and DIA China SMO Collaborative Group, Due to the many challenges faced by the Chinese CRC community, the pressure on SMOs is greater than that of CRCs
.

The R&D client learned from the above-mentioned clinical research institution of Zhengzhou Cancer Hospital in Henan that the institution manages SMO with excellent candidates, such as: 9 SMO companies will be selected in 2021, 5 will be selected, and 3 will be cultivated for improvement
.
The CRC's work in the hospital is managed by the filing system.
At present, there are more than 300 CRCs who have been selected as the best SMO companies for filing in the institutional office
.

The above-mentioned preference for SMO by cancer hospitals also reflects the fact that the development of SMO has intensified the competition in research and development.
In view of the fact that the project unit yield is reduced, the average basic cost per case increases, and the project management cost increases, this has caused a greater impact on the SMO company.
pressure
.

Zhao Jie mentioned that some institutions put too high requirements on SMO selection, management exceeded the scope, and even participated in the setting of prices and additional conditions, which increased the operating cost of SMO
.
"In view of the institution's own positional advantages, SMO can only accept it, but this does not conform to the law of enterprise operation, and has affected the development of the overall clinical research field.

How should SMO develop?"

Regarding "how to develop SMO", Song Qingchun thought about the best development model for Chinese SMO companies
.
She believes that it can develop into a leading SMO company with the model of "city concentration, center concentration, and optimization first"
.

"The management of CRC is reflected in the meticulous management of working hours, the centralized layout, and the cultivation of talent reserves
.
Clarify the clear career goals and development paths of the existing CRC and project managers, so that everyone knows what the goal is, and strengthen training at the same time.
, strengthening the company's internal training system is the cornerstone of the sustainable and stable development of SMO in the future
.
" Song Qingchun said
.

R&D customers received feedback from many institutions during the visit.
Although there are still urgent problems to be solved in SMO, CRC and clinical research institutions, the industry and research institutions have increasingly recognized the professionally responsible CRC
.
Ms.
Leng Xiaoxia, the former head of the business development department of Hangzhou Simo Pharmaceuticals and the current executive deputy general manager of the marketing department of Yidisi, has experienced the first round of SMO growth.
She believes that now is a good time for the second growth.
SMO Although the pressure of working with CRC is great, it is their duty to work with institutions to ensure the quality and progress of trials, and ultimately customers will still pay for high-quality clinical trial services
.