How To Conduct Effective Clinical Research Management

By Sarah Reynolds


Clinical research is a sector of health care study that deals with the efficacy and safety of treatment regimens, medication devices and diagnostic products envisioned for human use. These elements could be used for diagnosis, prevention, treatment or dismissing disease symptoms. Clinical trials are used to collect evidence which is then used to establish new and improved treatment procedures. Due to the compound nature of this branch, clinical research management must be undertaken to ensure optimal use of the available resources.

Very many people take part in these medical studies on a voluntary basis. Healthy volunteers involved with ambitions of contributing to the scientific development and help those in need. Volunteers with diseases also participate with hopes that they will receive advanced treatments. These people also get a lot of care and attention from members of the clinical trial. This study provides promise that more effective treatments for chronic medical conditions will be developed. As to minimise the risks on the lives of participants, all trial activities are highly systematised.

These measures include strict protocols to be followed during execution of different activities. Apart from that, an informed consent concept is used. This concept involves full disclosure of all information concerning the trial. A team is assigned the role of explaining this information to these volunteers so that they are acutely aware of the procedure, duration, potential benefits, risks and purposes. These people are also free to discontinue participation anytime they feel like it.

These studies require a lot of resources. In as much as the local government allocates resources for medical study and development, such massive projects require more sponsorship. Various organisations and individuals usually sponsor such activities. These include pharmaceutical companies, voluntary groups, physicians, foundations and medical institutions. In addition to that, the National Health Department and Department of Veterans Affairs also provide some resources.

Several challenges confront these trials. These challenges include time, resources, scope, and objectives. These constraints vary widely in intensity depending on size and complexity of the particular task. The trial team has to work in close collaboration to ensure that the predefined goals and ambitions are accomplished within the set time bound. Therefore, it is highly imperative that management protocols are established to ensure resource optimisation.

During such endeavours, project managers must undertake extensive planning. A project definition document should be used to carry out the work plan. Proper preparation promises reduced duration, costs and increased quality outcomes. Work scope and definitions are very crucial during the planning process. Project definition includes an overview, objectives, scope, risks and assumptions, approach and organisation.

With a clear and precise definition in place, the team should also work on creating a horizon. The horizon is more of an action plan, and it is determined by the terms used in the definition. It provides the researchers with a strategic procedure to be used in accomplishing task goals and providing the desired deliverables.

Therefore, it is essential that the manager who is assigned such tasks has the necessary knowledge and experience. With the right expertise, overseeing project activities would be easy. A beginner, however, would have so much trouble keeping up with pace. This manager must also be humane, flexible and good with people.




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