Briefing Document (BRD)
A well-written briefing documents (BRD) is crucial to smoothen the regulatory outcome by providing comprehensive information like pre-submission meetings and protocol assistance that shape the clinical research.
Display strong medical acumen through expert documentation.
Document your clinical trial data through all phases of drug development
studies to secure regulatory approvals with efficient documentation.
Medical writing is the practice of creating summaries of your clinical trials in the form of well-structured scientific articles or documents. It is primarily written for regulatory bodies as supporting assets to smoothen approvals and includes clinical data, submission documents, and post-approval documents.
IQA understands the importance of maintaining the integrity of these documents for streamlined approvals. Therefore we designed a solid team of specialist medical writers who have a proven track record to deliver accurate documentation for clinical and regulatory purposes upholding the quality and industry standards well within the timelines.
At IQA, we have developed diverse knowledge and experience after working extensively in life sciences industry, assisting clinical researchers, and academia with regulatory documentation.
Briefing Document (BRD)
A well-written briefing documents (BRD) is crucial to smoothen the regulatory outcome by providing comprehensive information like pre-submission meetings and protocol assistance that shape the clinical research.
Case Report Form (CRF)
Case Report Form (CRF) is critical to ensure data quality and mitigate discrepancies during clinical trials by defining study protocol. The digital form of the document is known as eCRF.
Clinical Evaluation Plan (CEP)
The clinical Evaluation Plan (CEP) represents the scope, methods, and structural format of executing a clinical research and evaluation process.
Clinical Evaluation Report (CER)
The Clinical Evaluation Report (CER) documents the conclusion of a clinical study of any treatment or device including the intended purpose, target patients, medical markers, and clinical benefits.
Briefing Document (BRD)
A well-written briefing documents (BRD) is crucial to smoothen the regulatory outcome by providing comprehensive information like pre-submission meetings and protocol assistance that shape the clinical research.
Case Report Form (CRF)
Case Report Form (CRF) is critical to ensure data quality and mitigate discrepancies during clinical trials by defining study protocol. The digital form of the document is known as eCRF.
Clinical Evaluation Plan (CEP)
The clinical Evaluation Plan (CEP) represents the scope, methods, and structural format of executing a clinical research and evaluation process.
Clinical Evaluation Report (CER)
The Clinical Evaluation Report (CER) documents the conclusion of a clinical study of any treatment or device including the intended purpose, target patients, medical markers, and clinical benefits.
Clinical Investigation Plan (CIP)
A Clinical Investigation Plan (CIP) outlines the design and implementation of a clinical study and provides information like objectives, methodology, and clinical study timeline to ensure ethical and regulatory requirements are met.
Clinical Investigation Report (CIR)
A Clinical Investigation Report (CIR) summarizes the results of a clinical trial through a detailed analysis of the study’s data and results. It is used to present the evidence to regulatory agencies to support the safety of the drug.
Clinical Overview (CLO)
A Clinical Overview (CLO) presents important information about a clinical study such as its purpose, design, patient population, interventions, and results facilitating a broad understanding of a clinical trial.
Clinical Study Report (CSR)
A Clinical Study Report (CSR) is a document describing clinical and statistical analyses of your clinical study explaining the critical design features, the plan, methods, and conduct of the study.
Clinical Investigation Plan (CIP)
A Clinical Investigation Plan (CIP) outlines the design and implementation of a clinical study and provides information like objectives, methodology, and clinical study timeline to ensure ethical and regulatory requirements are met.
Clinical Investigation Report (CIR)
A Clinical Investigation Report (CIR) summarizes the results of a clinical trial through a detailed analysis of the study’s data and results. It is used to present the evidence to regulatory agencies to support the safety of the drug.
Clinical Overview (CLO)
A Clinical Overview (CLO) presents important information about a clinical study such as its purpose, design, patient population, interventions, and results facilitating a broad understanding of a clinical trial.
Clinical Study Report (CSR)
A Clinical Study Report (CSR) is a document describing clinical and statistical analyses of your clinical study explaining the critical design features, the plan, methods, and conduct of the study.
Clinical Trial Protocol (CTP)
In a Clinical Trial Protocol (CTP) you outline the design, conduct, and management of a clinical trial by defining the study population, interventions, and procedures for collecting and analyzing data.
Drug Safety Update Report (DSUR)
The DSUR is an analytical document that summarizes the safety of medicinal products like drugs, and vaccines observed during their development or clinical trial phase.
Informed Consent Form (ICF)
An Informed Consent Form (ICF) is a document intended for potential participants to give details about a clinical trial like purpose, risks, benefits, and the procedures involved.
Investigator’s Brochure (IB)
An Investigator’s Brochure (IB) document is submitted to the study investigators and provides a comprehensive overview of a clinical trial. It presents details like study design, patient population, interventions, endpoints, and data management procedures.
Risk Management Plan (RMP)
The Risk Management Plan (RMP) is a documented list of measures to minimize the risk of drugs used for the progress of post-marketing surveillance and applying for a marketing authorization.
Standalone Quality Control Services (QC)
Ensure the quality and accuracy of your clinical data collected during the study process through Standalone Quality Control (QC) services to avoid errors and ensure compliance with regulatory requirements.
Summary Clinical Efficacy (SCE)
A Summary of Clinical Efficacy (SCE) is a document that summarizes the data relevant to prove the efficacy of a drug in the intended population in producing the beneficial effect.
Summary of Clinical Safety (SCS)
Through the Summary of Clinical Safety (SCS) you provide a summary of the safety profile of a medical intervention, such as a drug, device, or procedure.
With IQA, you get access to skilled medical writers who work specifically to address the needs of your clinical research, bring our expertise in transforming complex data, and generate accurate and quality documentation.
Enrich your clinical trials with expertly written documents across phases to ensure regulatory approval and faster market release.
