Trends in the contract research organization (CRO) industry

As the macroeconomic trend of the world is improving, the R&D budgets of pharmaceutical companies are gradually increasing, which will effectively drive the rapid development of the whole CRO industry. According to the relevant authorities, the global medical R&D expenditure is expected to reach US$140 billion by 2020, and the market volume of the pharmaceutical industry and CRO industry is expected to further expand in the future.The CRO industry can effectively help pharmaceutical companies improve R&D efficiency and reduce costs. At the same time, benefiting from favorable policies, convenient financing and pharmaceutical market expansion, China's CRO industry is currently entering a golden development period, driven by a double rise in R&D investment and CRO penetration, with full growth momentum. CRO industry has the following development trends worthy of attention:

1. CRO market is growing fast and has great potential: under the catalyst of various factors such as continuous growth of domestic pharmaceutical market demand, intensified segmentation trend of pharmaceutical industry and the implementation of consistency evaluation standards, CRO enterprises have emerged in large numbers in China, enhancing their competitiveness by various means such as investing in R&D funds and attracting domestic and foreign talents, building an indispensable and important component of the total price of the new drug R&D industry chain, which has also become the The rapid development of China's CRO industry has been a driving force.

2. China joins ICH, the pharmaceutical industry is formally aligned with international standards: In 2017, CFDA (China Food and Drug Administration) and ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use) announced simultaneously that ICH officially approved CFDA to become its member. 2018 CFDA successively applied several ICH secondary guidelines to align with international standards, which means that the Chinese pharmaceutical industry will compete in the global landscape. This change has greatly stimulated the development of the domestic CRO industry and increased the trust and willingness of overseas pharmaceutical companies to cooperate with the domestic CRO industry. At the same time, the abundant domestic resources and cost advantages also give domestic CRO companies stronger competitiveness.

3. Domestic CRO penetration rate is expected to further increase, with high development potential: the global CRO business penetration rate continued to grow from 32.2% in 2013 to 36.5% in 2017, and is expected to grow to 45.8% in 2022. As an emerging market in CRO industry, China's market penetration rate is low, but with the introduction of national policies to encourage the development of new drugs, domestic pharmaceutical companies are investing more in R&D, and more and more pharmaceutical companies will rely more on CRO services, and the business penetration rate of domestic CROs will increase rapidly in the future.

Business pain points and requirements

CRO industry as a typical project management type of enterprises, project management requirements are always the core of the entire business, from project management derived from the following business pain points and needs:

1. Difficult to manage with scattered personnel around the world: The personnel of CRO companies are usually scattered in different regions and countries around the world. It is especially difficult to manage the integration of project resources, effective utilization and reasonable assignment of tasks.

2. Human resources integration, intra-group project human resources transfer: affected by the distribution of resources, project resources in the allocation of various projects, the need for human resources transfer between various legal entities is particularly obvious. It is necessary to record detailed detailed records of personnel interactions and complete internal inter-company settlement on a regular basis, with a large amount of data and complex settlement rules.

3. Project team business models are diverse: CRO industry involves a variety of project delivery work, such as clinical testing, patient tracking, report writing, database building, data validation, medical translation, etc., the management model of different businesses are different, for the flexibility of the ERP system put forward high requirements. The primary business pain point brought about by the diversification of business models is the diversification of project process management, project planning and follow-up, project task allocation and response, project issues and records, project work time collection and billing, project cost advances and invoicing, and a series of business needs to be different because of the different project teams.

4. Diversification of project revenue models: The business pain points brought by the diversification of business models also include the recognition of financial revenue. For different business forms, the criteria for recognizing project revenue are different, such as recognizing revenue according to deliverables, or recognizing revenue according to the number of patients enrolled, or recognizing revenue according to milestones, or recognizing revenue according to the workload of medical translation, etc. There is a strong demand for the rigor of revenue recognition rules, the accuracy of revenue calculation and the timeliness of revenue recognition.

5. Security of project deliverables and version change records: The deliverables in CRO industry are mainly medical reports, data analysis charts and other documentary deliverables, which have high requirements for the security of the deliverables during the delivery process, and the long writing cycle of the deliverables is also extremely important for the iterative management of versions.

Our solutions

Based on Microsoft Dynamics 365, Office 365, Power BI, Azure Cloud and other products and services, we focus on the current CRO industry pain points and CRO industry development trends to provide a set of efficient, reliable and targeted solutions for the CRO industry.

Pain point 1: The location of personnel is scattered all over the world

Solution:

D365 creates project human resource files to effectively manage detailed information about each employee, such as employee information, location, skills information, project experience, medical license certificates, etc. It provides the necessary judgment information for project personnel management in coordinating personnel to different project locations. Also, combine with Power BI's powerful chart visualization to visually analyze the distribution of employees around the world.

In terms of staff time utilization, D365 provides efficient and comprehensive staff time analysis, showing different perspectives on staff contribution and value-added margin, improving management efficiency in terms of staffing and reducing communication and management costs.

Benefits:

Improve the effective work hours utilization of human resources in CRO projects.

Improve the efficiency and accuracy of human resources in project allocation and project scheduling, and reduce idle time.

Reduce communication costs between project managers and CRM (Crew Resource Manager), and increase the efficiency of project team preparation.

CRM can allocate project human resources according to their skills, work history and role classification.

Pain point 2: Human resources integration, intra-group project human resources transfer

Solution:

To improve the utilization of project human resources, the collaboration of project resources among different legal entities is especially frequent. D365 supports powerful functions such as cross-legal entity reporting of work hours, cross-legal entity expense reimbursement, cross-legal entity procurement application, inter-company transactions, and automation of internal company transaction invoices, which effectively supports the orderly conduct of multi-legal entity business.

Benefits:

Cross-legal entity transactions, regular issuance of inter-legal billing, pending settlement costs are traceable .

Automated settlement, linked posting, improve the efficiency of account processing and reduce human operation errors.

Pain point 3: Diversified project team management model

Solution:

D365 provides a full range of project lifecycle management solutions, offering a full range of functional coverage from the pre-sales stage, concept stage, execution stage and lifecycle operation stage of a project. For different forms of business units, it provides tailored management approaches in various aspects such as project planning, task management, man-hour management, project cost management, issue management, and knowledge management. The different types of deliverables in CRO's contract management process also pose a challenge to the recording of contracts. For example, patient enrollment requires recording not only daily test enrollment, but also timely response to possible changes such as patient shedding and study discontinuation. In medical writing, contracts agree on the corresponding workload, but the long span of the contract cycle also requires effective tracking of contract completion. In the business scenario of database construction, programming, and data statistics, different work contents such as subscription fees for database storage platform, development fees for programming, and data statistics cleaning need to be recorded in detail according to different business requirements.

Benefit:

The multi-project team achieves standardized management while retaining individuality.

Pain point 4: Diversification of project revenue models

Solution:

Different project teams are managed in groups according to certain characteristics, and revenue recognition rules are set in advance. Different project teams enter into daily update work according to different business, such as deliverables update, billing work hours reporting, patient entry group data update, milestone status change and a series of other operations. Project financial business integration, the system automatically evaluates project revenue proposals at the end of the month, and PM's supporting documents for revenue recognition are uploaded to their respective projects to keep an audit trail and guarantee the orderly revenue realization.

Benefits:

Significantly improve the efficiency and accuracy of revenue recognition.

Project audit information can be viewed very easily.

Pain point 5: Project deliverables information security and version iteration

Solution:

Aiming at the CRO industry's special focus on project knowledge storage and different forms of deliverables management and version management of deliverables, we combine the advantages of two Microsoft products, D365 and Share Point, to effectively combine the two. Share Point carries out knowledge storage and management, while D365 categorizes and displays the knowledge catalog, effectively managing projects with different milestones, different project teams and different deliverables management needs in an orderly manner.

Benefits:

Convenient storage and viewing of project documents

Microsoft Cloud Services endorsement improves the security and confidentiality of your company's knowledge base.

Historical versions can be retrieved efficiently at any time as needed.

Reference Case: ClinChoice Inc

Customer Introduction

ClinChoice (former name: Fountain Pharma) is an international CRO company that provides clinical development services in line with ICH standards and is a leader in the CRO industry. Since its establishment in 2007, ClinChoice has established a global branch structure in several countries and regions, with more than 1700 employees worldwide and a growing clinical operations team in 55 cities in mainland China. ClinChoice is going global and making its unique contribution to global health.

Business Needs, Solutions and Project Benefits

ClinChoice, which is growing at a high speed, is providing high level of services to its customers, while the increasingly complex management and accounting needs are not satisfied by the original ERP system. The demand for multi-dimensional profitability analysis with project management as the core has led to the launch of D365 in ClinChoice.

In order to meet the needs of ClinChoice's rapid development and efficient and accurate decision-making by management, on the one hand, it is necessary to build a set of solutions for project management within ClinChoice Group that meet business needs and cover the whole life cycle of projects. On the other hand, it is also necessary to build a set of multi-dimensional analysis system tailored to ClinChoice's characteristics, build a management cockpit, and provide powerful big data support for ClinChoice Group's operation.

Ø Establish project 360 view for project management to improve project management, increase employee happiness and reduce communication costs.

Ø Establish a multi-dimensional accounting system for financial management, and analyze profitability from profit center, legal entity, project, contract, customer and other multi-dimensions.

Ø Customized management analysis reports for ClinChoice management, making full use of D365's powerful expansion capability, and at the same time, using the powerful integration capability of D365 and Power BI for data visualization.

Partner Introduction

IWS is a service provider, consultant and developer of Microsoft ERP and CRM solutions, and was qualified as a Microsoft Gold Partner in 2010, certified as "Double Soft" in Xiamen in 2012, and became a member of Microsoft Global President's Club in 2013. We have a Microsoft R&D center in Xiamen to develop ERP and CRM industry solutions. Our main solution capabilities include supply chain, lean manufacturing, automated warehousing, smart manufacturing, data collection, Industry 4.0, distribution and retail, group finance, business intelligence, project management, human resources, product design, collaborative office, e-commerce, ERP peripheral applications, etc.

Contact Information

For more information about Microsoft Gold Partner IWT, please visit their corporate website at http://www.xmiws.com

Tel: 0592-5962617

Email:marketing@iwstech.com