Research On Risk Mamagement Of CRO Commisioned Generic Projects In TS Enterprises

High quality generic drugs are popular in the market because of their low R&D cost,relatively short investment cycle and low price,which can improve the accessibility of drugs and reduce the burden of medical insurance payment.In the era of increasingly fierce global com-petition,in recent years,pharmaceutical enterprises tend to entrust gene-ric pharmaceutical projects to more professional CRO enterprises through the establishment of contracts for research and development,and use li-mited resources to quickly enrich product pipelines,and improve the co-mpetitiveness of enterprises.A series of uncertain factors,such as value-culture difference,information asymmetry,technology cost input dispute among organizations,bring a series of risks to the success of the gener-ic drug Commission project.If not effectively controlled,it may lead to the extension of the project cycle,the out of control of key technologi-es,the inability of product quality to meet the market demand,and ulti-mately the loss of market value due to the lack of competitiveness of the project products Therefore,it is very important to study the risk m-anagement of the project entrusted by the generic CRO for the success ofthe project.From the perspective of the client's pharmaceutical factory,the paper uses the balanced scorecard method(BSC)to transform the company's strategy into departmental performance in accordance with the risk management-integration framework theory.Then design the relationship matrix between department performance and project performance according to the quality function deployment method(QFD),The generic drug CRO commission project business is divided into 6 stages,combined with the process failure mode and consequence analysis method for risk assessment,Recognize the risk of project performance failure that has a greater impact on the company's strategy at each stage,and propose targeted countermeasures.The specific research results are as follows:(1)The relationship matrix of department performance and pro-ject performance based on BSC-QFD is designed.Firstly,the company's strategy is decomposed into department level performance and the depa-rtment performance weight that affects the company's strategy is determ-ined.Then,the project performance weight that affects the realization of department performance is determined by the matrix,and the risk value of single project performance failure risk factor is calculated by the no-rmalized weight coefficient Correct and ensure that risk management ai-ms to achieve the company level strategy.(2)According to the life cycle characteristics of project mana-gement,the entrusted project business of generic CRO is divided into s-ix stages:project initiation,contract preparation,contract conclusion,co-ntract execution,contract acceptance and project operation.With the hel-p of expert interview method and questionnaire method,quantitative dat-a are obtained,risk is measured by process failure method(PFMEA),an-d the risk of project performance failure,which has great influence on the company's strategy,is finally confirmed through the correction of n-ormalized weight factors related to strategy department performance.Inc-luding the controllability of raw materials in the project approval stage,the reputation of CRO enterprises in the industry in the contract prepar-ation stage,the flexibility of contract contents in the contract conclusion stage to cope with changes in regulatory environment,the response of CRO enterprises in the contract execution stage to changes in policy fa-ctors,the continuity of service quality of suppliers in the contract acce-ptance stage,and the quality stability of key materials in the project pr-oduction stage.(3)According to the quality function deployment and expert i-nterview method,find out the risk sources and formulate corresponding countermeasures.The main countermeasures are:select key raw material-is related declaration in the project approval stage,or obtain control rig-ht through holding or equity participation,select more than 2 suppliers,strengthen audit on suppliers and formulate relevant constraint measures;In the contract preparation stage,the reputation of CRO enterprises is e-xamined from three aspects:financial status,customer satisfaction and s-ocial responsibility.The CRO enterprises that do not meet the requirem-ents are not considered to cooperate.The CRO enterprises with low cu-stomer satisfaction should be analyzed for the reasons,and the obligati-ons and responsibilities should be clearly defined in the contract.At the contract conclusion stage,the overall objectives of contract research are clearly put forward,and based on the changing trend of laws and regul-ations clear technical requirements,clear supplementary agreements with unclear trends,and select appropriate pricing scheme to link the respon-sibility for regulatory changes with performance;In the contract impleme-ntation stage,both parties shall establish a monitoring and response me-chanism for policy changes,with responsibilities assigned to each person.For major changes,the necessity of risk decision making project contin-uation shall be assessed,and if necessary,the project shall be suspende-d,terminated or sold to transfer risks.In the contract acceptance stage,when there is a major change in the quality of key raw materials,the necessity of assessment of supplementary research shall be interrupted,and when the price of raw materials is out of control,Study the mater-ials of alternative suppliers,investigate the reasons for unstable supply of raw materials,and establish strategic cooperation relationship with su-ppliers if necessary;assist the production department to review the qual-ity and technical information of suppliers during the project production stage,and increase the verification batch for key materials sensitive to product quality to improve the internal control standards of materials.