20+ Gainwell Technologies Interview Questions and Answers

Adverse event is any undesirable medical occurrence while adverse reaction is a specific type of adverse event caused by a medication.

• Adverse event can be caused by any medical intervention or procedure while adverse reaction is specifically caused by a medication.

• Adverse event can be expected or unexpected while adverse reaction is always unexpected.

• Example of adverse event: a patient develops a fever after surgery. Example of adverse reaction: a patient develops a rash afte...read more

Handled cases include data cleaning, analysis, visualization and reporting for various industries.

• Data cleaning and analysis for a retail company to identify sales trends

• Visualization of customer behavior for a telecommunications company

• Reporting on website traffic for an e-commerce business

• Data analysis for a healthcare provider to improve patient outcomes

• Cleaning and analyzing survey data for a non-profit organization

Congenital anomaly refers to a physical or structural abnormality present at birth.

• Seriousness criteria of cases depend on the type and severity of the anomaly.

• Some congenital anomalies may be minor and have little impact on health, while others can be life-threatening.

• Examples of congenital anomalies include heart defects, cleft lip and palate, and neural tube defects.

• Congenital anomalies can be caused by genetic factors, environmental factors, or a combination of both.

• Early...read more

Solicited report is a report requested by an authority while spontaneous report is a voluntary report by an individual.

• Solicited report is requested by an authority or organization.

• Spontaneous report is voluntary and not requested.

• Solicited report is usually for a specific purpose or event.

• Spontaneous report is usually for unexpected events or adverse reactions.

• Examples of solicited reports include clinical trial reports and regulatory reports.

• Examples of spontaneous reports ...read more

There are four phases of clinical research: Phase 1, Phase 2, Phase 3, and Phase 4.

• Phase 1: Focuses on safety and dosage in a small group of healthy volunteers.

• Phase 2: Expands to a larger group to see if the treatment is effective.

• Phase 3: Compares the new treatment to standard treatments in a larger group.

• Phase 4: Post-marketing studies to monitor the treatment's long-term effects.

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

• Pharmacovigilance involves monitoring and evaluating the safety of pharmaceutical products.

• Adverse events are any undesirable experience associated with the use of a medical product.

• Examples of adverse events include side effects, allergic reactions, and medication errors.

• Pharmacovigilance aims to improve pat...read more

SUSAR stands for Suspected Unexpected Serious Adverse Reaction. Regulatory authorities include FDA, EMA, MHRA, etc.

• SUSAR refers to adverse reactions that are unexpected, serious, and suspected to be caused by a drug or medical product

• Regulatory authorities such as FDA (Food and Drug Administration), EMA (European Medicines Agency), MHRA (Medicines and Healthcare products Regulatory Agency) oversee reporting and monitoring of SUSARs

• Reporting SUSARs is crucial for ensuring the ...read more

Reports can be categorized into operational, tactical, and strategic reports.

• Operational reports provide day-to-day information on business activities.

• Tactical reports provide information on short-term goals and objectives.

• Strategic reports provide information on long-term goals and objectives.

• Other types of reports include financial reports, performance reports, progress reports, and incident reports.

• Examples of reports include sales reports, inventory reports, budget report...read more

ICH-GCP guidelines are international standards for designing, conducting, recording, and reporting clinical trials.

• ICH-GCP stands for International Conference on Harmonisation - Good Clinical Practice.

• These guidelines provide a unified standard for the European Union, Japan, and the United States.

• They ensure the protection of the rights, safety, and well-being of trial subjects.

• ICH-GCP guidelines cover aspects such as trial design, conduct, monitoring, auditing, and reporting...read more

Medra coding is a standardized medical terminology used for reporting adverse events and drug reactions.

• Medra stands for Medical Dictionary for Regulatory Activities.

• It is used by pharmaceutical companies, regulatory agencies, and healthcare professionals.

• It helps in identifying and analyzing adverse events and drug reactions in clinical trials and post-marketing surveillance.

• Medra codes are hierarchical and can be expanded to provide more specific details.

• Example: Medra code...read more

Pharmacovigilance involves several phases including signal detection, data collection, data assessment, risk management, and communication.

• Signal detection: Identifying potential safety issues through various sources such as clinical trials, spontaneous reports, and literature reviews.

• Data collection: Gathering information on adverse drug reactions (ADRs) from healthcare professionals, patients, and regulatory authorities.

• Data assessment: Analyzing and evaluating the collecte...read more

New drug invention refers to the discovery and development of a novel medication to treat a specific disease or condition.

• New drug invention involves a rigorous process of research, testing, and approval by regulatory agencies.

• It can take years and millions of dollars to bring a new drug to market.

• Examples of recent new drug inventions include the COVID-19 vaccines and treatments for rare diseases like spinal muscular atrophy.

Phase 4 trial is the post-marketing surveillance phase of drug development.

• Phase 4 trial is conducted after a drug has been approved by regulatory agencies.

• It is also known as post-marketing surveillance phase.

• The aim is to monitor the long-term safety and effectiveness of the drug.

• Phase 4 trials involve a large number of participants and can last for several years.

• Examples of drugs that have undergone phase 4 trials include Lipitor and Viagra.

Clinical research is the study of health and illness in people, involving human participants to test new treatments or interventions.

• Clinical research involves conducting studies with human participants to evaluate the safety and efficacy of new treatments, interventions, or medical devices.

• There are typically four phases of clinical research: Phase 1 (testing for safety), Phase 2 (testing for efficacy), Phase 3 (large-scale testing), and Phase 4 (post-marketing surveillance)...read more

Adverse events are unexpected or harmful reactions to medical treatments or interventions.

• Adverse events can range from mild to severe and can include side effects of medication, complications from surgery, or reactions to medical devices.

• Adverse events can be caused by errors in medical treatment, patient factors such as allergies or pre-existing conditions, or unknown factors.

• Adverse events are closely monitored in the medical field to improve patient safety and prevent fut...read more

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

• Pharmacovigilance involves monitoring the safety of medications post-market approval.

• It includes collecting and analyzing data on adverse drug reactions.

• Pharmacovigilance aims to improve patient safety and minimize risks associated with pharmaceutical products.

• Examples of pharmacovigilance activities include ...read more

Diabetes is a chronic condition that affects how your body turns food into energy.

• Diabetes is characterized by high levels of blood glucose resulting from defects in insulin production, insulin action, or both.

• There are three main types of diabetes: type 1, type 2, and gestational diabetes.

• Symptoms of diabetes include frequent urination, increased thirst, unexplained weight loss, and fatigue.

• Treatment for diabetes includes medication, insulin therapy, diet and exercise.

• Compli...read more

Form 21 CFR is a document used by the Food and Drug Administration (FDA) to regulate medical devices.

• Form 21 CFR is a regulation set by the FDA for medical devices.

• It outlines requirements for manufacturing, labeling, and marketing medical devices.

• Compliance with Form 21 CFR is necessary for selling medical devices in the US.

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

• Pharmacovigilance involves monitoring the safety of medications post-market approval.

• It includes collecting, analyzing, and reporting adverse drug reactions.

• Pharmacovigilance aims to improve patient safety and minimize risks associated with pharmaceutical products.

• Examples of pharmacovigilance activities incl...read more