PROJECT MANAGEMENT

Think of a large project management office

When analyzing strategies aimed to improve the rate of scientific productivity, it should be considered that a new drug takes an average of 10 years to complete the cycle from its initial discovery to its marketing, of which at least 6 or 7 years correspond to clinical trials. Pharma's level of production has remained at stable levels for the past 10 years, and there is no realistic expectation of a sudden increase in such levels in the short term. Innovations in the area of technology are required to achieve substantial advances in precision or personalized medicine, in order to be able to get the right patient to take the proper treatment at the appropriate dose from the beginning.

 

The increase in the demand of the market, the reduction of the terms of scientific research and development and the fierce competition, mark an accelerated rhythm to the pharmaceutical industry. It could be said that pharmaceutical companies suffer from the legacy of old management styles in which the culture shared similarities with the public sector. Massive organizations need to change and change fast if they are to survive.
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There is currently a growing tendency among pharmaceutical companies to seek alliances through mergers or acquisitions, developing new business schemes, analyzing new emerging international markets, seeking synergies with pharmaceutical giants, reformulating the classification of products or biosimilars and implementing new strategies for reduce the marketing terms, all of which reflects the growing interest in applying the best practices of project management in an increasingly complex industry.

Project management is the key

When we talk about the Project Management for the development of new medicines we refer of a fairly focused discipline with relatively little time in development. The role of project manager is complex and demands skills and qualities in specific areas such as communication, decision making, delegation of responsibilities and risk assessment. Must be able to take on the daily challenges inherent in managing projects, such as:


• Usually, Organizations lack an appreciation of the importance of project management, especially the executive board

• Reporting progress and financial burn down to boards and investors is very difficult

• Projects require massive coordination between R&D, regulatory, legal, finance, supply chain, sales, and marketing

• Projects lack sponsorship or visibility from top decision makers

• Research projects are usually geographically distributed and disconnected

• Resource pools are often distributed, with poor overarching resource management function

• Lack of a single project management process framework

• Lack of specialized pharmaceutical project management skills

• Projects are strongly regulated with complex compliance processes

• IT and back-office functions including large CRO projects are often outsourced

 

The growing importance of project management is determined by being a key and integral part of the entire production process. The definition provided by the PMI of a project is "a temporary effort made to create a product, service or unique result". The projects are "temporary" and, therefore, different from the operations, whose main objective is to maintain the main business. This is how effective management of pharmaceutical projects is able to organize and manage resources efficiently so that the project is completed within the scope, quality, time and budget defined.

 

Project Managers must be analytical and determined people with negotiating skills and ability to resolve conflicts and communicate the progress of results in a clear and effective manner. These skills are not usually associated with people in the scientific or academic area. Due to the specificity of these skills, there is a significant increase in management consultancies that offer specialized pharmaceutical project management services. The development of contracts and the manufacturing organization (CDMO) have become a fundamental part of the success of the pharmaceutical industry, which requires a reliable CDMO. In turn, CDMOs can help promote trust and ensure timely delivery according to budget, facilitating communication through the providing of qualified project managers.

 

Taking into account all the variants inherent in the scientific research process related to the pharmaceutical industry, project management should cover the following activities:

Boca Raton Clinical Research follows HIPAA Guidelines and maintains patient confidentiality. Patient registration, medical history, family history and trial participation is stored in our patient database and is never shared or sold.

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We have extensive experience in a variety of therapeutic areas by managing studies in USA, Latin America, Caribbean Islands and Central America. We have built strong business relationships with main researchers in several cities in the referred regions.

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