Clinical Research

Clinical Trial Management

A Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering or verifying the Clinical, Pharmacological (including pharmacodynamics and pharmacokinetic) or adverse Effects with the objective of determining safety and efficacy of the new drug. Clinical Research Industry has grown around the world at an unparalleled rate in the past few years. It has opened up new vistas of employment for a large number of people. The Clinical Trials market worldwide is worth over US$ 45 billion and the industry has employed an estimated 2,10,000 people in the US and over 70,000 people in the UK and they form one third of the total Research and Development staff. These large numbers can be attributed to the fact that this industry offers lucrative employment opportunities. The average nominal annual salary growth across all the positions is 4% as against less than 1% for other segments.

Work Profile

    -Clinical Research Coordinator (CRC)
    -Clinical Research Associate

Clinical Research Coordinator (CRC)

The Clinical Research Coordinator (CRC) is responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of the Principal Investigator (PI).

Work Profile

    -All trials are conducted ethically, as defined by the Declaration of Helsinki, rigorously, as defined by the International Conference on Harmonization Guidelines (ICH).
    -Benefits outweigh risks for each patient.
    -Rights, safety and well-being of patients prevail over science.
    -All available non-clinical and clinical information on any investigation agent can support the trial as designed.
    -All trials are scientifically sound and clearly described.
    -All clinical trials have current Institutional Review Board approval.
    -Medical decisions and care are the responsibility of qualified health care professionals, specifically physicians and, if applicable, dentists.
    -Everyone involved in the clinical trial is qualified by training, education and experience.
    -Informed consent is given freely by every participant.
    -All study documentation is recorded, handled and stored to allow accurate reporting, interpretation and verification.
    -Confidentiality of subjects is respected and protected.
    -Investigational products maintain Good Manufacturing Practice in storage, manufacturing and handling.
    -Systems to ensure quality are implemented in all aspects of the trial.

Clinical Research Associate (CRA)

CRA Is key participant in the design, implementation and monitoring of clinical trials, preparation of integrated medical reports, INDs, Investigational Device Exemptions (IDE), periodic reports, New Drug Applications (NDAs) etc. Participates in design and writing of protocols, case report forms and informed consent forms for clinical trials. Productive in recruitment/selection of new investigators, contract research organizations and outside vendors. Responsible for planning and implementing all activities required to conduct and monitor complex clinical trials and ensures that Good Clinical Practices (GCP) are followed. Conducts site visits pre-study, at study initiation, at regular intervals during the study and at study closeout. Monitors investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary. Ensures that Case Report Forms (CRF) are reviewed in a timely fashion and submitted to the data management group. Involved in the compilation/writing of integrated medical reports and clinical sections of INDs, IDEs, New Drug Applications (NDAs) etc. Assists in preparation of presentations and manuscripts of scientific meetings and technical journals. Attends scientific/professional meetings and training courses as appropriate.

Clinical Data Management

India has developed into a super power for IT skills and has become a major hub for pharmaceutical and biotech manufacturing and contract research, the outsourcing business in various other segments is also exhibiting promise. Clinical trial data management and statistical analysis is one such area which is growing rapidly, accompanied by a variety of players entering into different models of this business. The author reflects on the data management business in India and reviews the emerging outsourcing models in this growing industry. He has also attempted to work out a break-even analysis considering the projected investment on high quality and costly infrastructure like; hardware, software and human resources to augment the business and regulatory requirements of the industry.

Clinical Data Analyst/ Manager

Primary responsibility is to ensure the validity of clinical trial data and format them for statistical purposes. Also designs collection instruments, sets up databases and tracks and manages the flow of data to and from the investigative sites. With supervision, establishes protocol-specific data review and entry guidelines to document data validation and formatting procedures and defines batch-ending programs. Monitors timely data entry. Reviews data discrepancies resolutions provided by the investigative sites and enters corrections in the database, as appropriate. Assists in the review of interim/final data listings prior to transmission to other groups or inclusion in interim/final reports. Is familiar with database management systems and the principles, organization and content of standard Case Report Form (CRF) libraries. Ensures that incoming CRFs are tracked in a timely manner prior to safety review and upon manual review. Is familiar with data coding of Standard Operating Practices (SOP) and coding dictionaries. Conducts database audits according to established SOPs and is familiar with the implementation of GCPs.

Pharmacovigilance

Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines. In general, Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to: identifying new information about hazards associated with medicines preventing harm to patients. Pharmacovigilance is particularly concerned with adverse drug reactions, or ADRs, which are officially described as: “A response to a drug which is noxious and unintended, and which occurs at doses normally use for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function.

Drug Safety Associate Responsibilities / Case Processing Expert/ Pharmacovigilance Associate

Drug Safety Associate manage activities relating to the collection, processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed products and investigational products. The DSA ensures timely submission of reports regulatory agencies in accordance with applicable regulations and that all inquiries from the FDA and other drug regulatory agencies are responded to in a timely manner. The DSA will respond to inquiries from health care professionals, consumers, and company personnel regarding safety issues with marketed products; prepare periodic comprehensive written reviews of all assigned AEs; identify potential sources of product litigation, extract AE data from various clinical trial cases and spontaneous sources; manage case-related information including interpretation of medical conditions, lab results, and procedures as well as compile complete narrative summaries; and ensure proper coding (MedDRA) into the global AE database.

Who hires Pharmacovigilance Professionals? People trained in Pharmacovigilance can find excellent work opportunities in following organizations:

Work Profile

    -Pharma-Companies ( Novartis, Dr. Reddys, Ranbaxy Etc)
    -Contract Research Organizations (CROs)
    -Biotech Companies.
    -IT Companies Like Accenture, TCS, Cognizant, Wipro, Mahindra Satyam Etc
    -Regulatory Authorities Such As DCG(I), FDA & CDSCO

Medical Writing

Medical writing is the activity of producing scientific documentation by a specialized writer. The medical writer typically is not one of the scientists or doctors who performed the research. A medical writer, working with doctors, scientists, and other subject matter experts, creates documents that effectively and clearly describe research results, product use and other medical information. The medical writer also makes sure the documents comply with regulatory, journal, or other guidelines in terms of content, format and structure. Medical writing as a function became established in the pharmaceutical world because the industry recognized it requires special skill to produce well-structured documents that present information clearly and concisely. A growing number of new drugs go through the increasingly complex process of clinical trials and regulatory procedures that lead to market approval. This drives a demand for well written, standards-compliant documents that science professionals can read and understand easily and quickly.

Medical Writer/ Content Writer/ Medical Data Reviewer

Responsible for the timely preparation, production and quality control of regulatory documents, including coordinating with regulatory project teams, creating editorial timelines and work flow specifications, scheduling and tracking documents, assessing documentation staffing needs, participating in “round-table” review of documents, establishing project-specific style guidelines, editing at various levels, writing and proofreading. Develops and updates specifications for the design, format production elements, tracking of regulatory documents and artwork used in regulatory documents. Hires, trains and supervises editorial temporaries and coordinates their work. Develops and updates departmental editorial style standards by preparing and revising a style guide. Provides guidance on writing to authors of regulatory submissions, and develops and updates general writing guidelines by preparing and revising an author’s guide.

Regulatory Affairs

Pharma regulatory affairs professionals play an essential role in ensuring all pharmaceutical products comply with regulations governing the industry. The regulatory function in healthcare industries is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Work Profile

    -Regulatory Professionals Are Employed In Industry, Government And Academia And Are Involved With A Wide Range Of Products, Including: Pharmaceuticals
    -Medical Devices
    -In Vitro Diagnostics
    -Biologics And Biotechnology
    -Nutritional Products
    -Cosmetics
    -Veterinary Products
    -The regulatory professional’s roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labeling and advertising and post market surveillance.

Regulatory Proffessional

Ensures all company products meet worldwide regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance. Responsible for the coordination and preparation of document packages for regulatory submissions ensuring compliance with the Food and Drug Administration (FDA) and international regulations/ interpretations. This may include the review, evaluation, and compilation of files and reports for submissions. Provides project team representation and direction in managing information from/to other departments (including R&D, Manufacturing, Quality Assurance, Quality Control, Medical Affairs, Marketing, and Clinical Affairs) regarding Regulatory submissions. This may include the preparation of outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to other departments. Reviews technical and clinical documentation and recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Researches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration. Is responsible for the timely completion of regulatory projects and submission of documentation to regulatory agencies. Develops and maintains current regulatory knowledge and keeps abreast of regulatory procedures and changes. May provide regulatory guidance to project teams and junior staff.