Clinical Research is different from other scientific fields of research and industry as it comes with its own set of challenges. Thus it needs a different set of management norms and skills from the regular commercial-banking-enterprise management course.
The success story of clinical research in India has had many factors: a vast and diverse pool of patients and diseases, lower cost of services, while at the same time easy availability of professional physicians, nurses and technical members, world class hospital services and the use of English in all business transactions. It was in the early 2000s that Clinical Research sought out Indian shores and grew rapidly to become a more than US $ 26 billion industry. But success comes with its own set of demands.
And one of them is an immediate need of skilled professionals. For those already in the industry, seeking to imbue professionalism in their employees and their subordinates, whilst handling clients, customers, vendors, complaints, meeting deadlines, managing time, using clear, concise and crisp communication skills both written and verbal and an ability to be translate directions into quick actions – is a daily battle.
With CROs branching out into drug development, Pharmacovigilence, Site management, Data management, Health Care management, Pharmaceutical management and logistical support, the challenge before the student, working professional and careerist in the clinical research industry now is to master the business needs of the organization. What companies and CEOs are looking for is not just science graduates good with research and analysis, but those who will be able to also handle management of materials, sales product management, research, development, production, project management money and man power. A serious shortage in such skills can only hamper the growth of the industry that is already in its next phase of evolution. This is where Clinical Research Management comes in. Not just for the young aspirant, but also the working professional, whose training could in turn propel growth of his own company.
Principles of Clinical Research Management
That Clinical Research is different from other scientific fields of research and industry as it comes with its particular sets of ethical guidelines, strict research norms, developing heavy and intimate personal relationships with people and patients, handling drugs and being ultimately responsible for a person’s health, dealing with vast and almost inexhaustible data for analysis - means its management norms should also be different from a regular commercial-banking-enterprise management course. This is why clinical research training institutes have evolved Clinical Research Management courses where management programmes especially segued to the needs of the clinical research industry are drawn up and conducted.
Management principles are necessary in almost every sphere of clinical research industry. For example, drug development is not just about formulating molecules, but also being a part of a team that will be developing the drug, which means handling people with skilled communication and leadership acumen. New health care discoveries and inventions obligate better marketing and management on the part of the company so that these drugs can reach people quicker. Project management in a clinical trials project for instance, will mean that the manager should be able to find out the exact requirement of the client, plan the project accordingly, evaluate risks, evaluate data quality, enforce GCP standards, get protocol approved, appoint external suppliers, draw up contracts, estimate budgets, work on deadlines and monitor the project rigorously till it is complete. Jobs that will call into play a person’s organizational and interpersonal skills, verbal and written communication flair and ability to be a team player, as well as lead the team, as more and more people in the clinical research industry, discover every day.
A large number of skilled manpower is also required by the industry because of its next phase of the growth. More and more Indian companies are looking to emerging markets like Thailand, Vietnam, Far East and even East Europe to set up facilities. A serious shortage of skilled manpower will hamstring such efforts, notwithstanding the ambition or the intent of the company to globalize itself.
Pharmacovigilance is the study of the adverse effects of a new drug, even after it is in the market. At the clinical trial stage, Pharmacovigilance involves drawing up protocols for setting up systems to assess the aim of the research, consider the reasons for recording and notifying adverse events at the trial and which events should be recorded and why. In each of these fields, one is judged not just on the understanding of his subject, but on his management skills and leadership acumen. Similarly, data management is at the core of clinical trials. Regardless of what the size of the trial, the number of patients involved, the drug details or the complexity of the tests, accurate results of any trial are determined by the quality of the data collected, the acumen with which it is collated, understood, and analysed. Failure to efficiently manage data results in compromising trial results, patient safety and validity of data.
A career in both Pharmacovigilance and Data Management is bright for the sincere and diligent student and the working professional. Career opportunities in Pharmacovigilance includes as a Clinical Pharmacovigilance Officer, Clinical Pharmacovigilance associate, Regulatory Affairs associate, Clinical Drug Safety Associate and Clinical CRF Designer among others. For Data Management students, careers will be as Data Entry Operator, Research associates, Data coordinators and statisticians, Database Programmer ,Database designer, Clinical data monitor, Data Validation executive, QA/QC executive, Project Manager among others.
India led in global clinical research outsourcing as its traditional educational strengths in science and English gave it a natural edge in the competition. However, with other countries catching on, professionalism and management skills is the next thing that alone will keep us ahead in the race.