Medical Writing

A clinical study protocol is a foundation of clinical trials. It is a document that describes the study objectives, design methods, assessment types, collection schedules, and statistical considerations for analyzing the data. The protocol outlines step for protecting subjects and procuring quality data. The document must be compliant with the applicable sections of the code of federal regulations (CFR) and the international conference on harmonization(ICH) guidelines. The investigator’s brochure is a document that describes the investigational product that is clinical stage of development. The document has to be compliant to the ICH E6 (R2) section 7 that provides the structure of the Investigator’s brochure document. Our expert team possess competencies in designing the clinical study protocol document. The team provides customized approach in designing the clinical study report depending on the country where the study shall be conducted. The team has mastered the opportunity to solidify the study design while providing the clear objectives and associated end points. The team has rich experience in drafting investigator’s brochure with cross functional expertise to include details about physical, chemical, pharmaceutical properties and formulation of the investigation drug. The team is noted for providing the drafted document with accuracy within the stipulated timelines.

This is an important foundation for the conduct of any clinical trial. It forms the basis to collect the safety and efficacy of the investigational product. Informed consent is a process that comprises of providing appropriate and obligatory information to the trail participants. Dairy cards are easy method of allowing the patients/trail subject to capture the initial response to the study drug that can be further evaluated by the investigator during the scheduled visits. The study assessment questionnaires stimulate in minimizing the bias and maximize the precision to the treatment. This gives a detailed vision to the realistic data revolving the investigational product. The proficient team at our organization help in advising the trail subject on the safety and efficacy of the investigational drug. The team clearly demonstrates the benefit risk assessment without any bias. The team is also multilingual which is an added advantage to connect to the trail subject to help them understand the clinical trial process. The team also provides support in analyzing the data points collected in dairy cards and study assessment questionnaires by providing the summary of the report to further analyze the safety and efficacy of the trial drug.

Medical monitoring plan is an essential document that ensures the clinical integrity of the trail subjects and provide accountability to safety during the clinical trial process. The monitoring plan includes details on the systematic risk based approach, emphasize on the monitoring of critical information. It also includes details on schedule visit and the types of visits to be conducted. The Safety management plan provides a structured methodology to the clinical safety management. It helps the clinical trial sponsors to minimize the safety risks in trial subjects. The safety reporting process can vary from individual case safety reporting to comprehensive aggregate reporting depending on the requirement of the regulatory authority. Our team provides immaculate support in organizing and designing the medical monitoring plan and safety management plan as per the good clinical practices guidelines.

This is a manual of procedures more like a ready reckoner that details the conduct of the study, facilitates the consistency in protocol implementation and data collection across involved trail subjects and investigator’s site. It is a detailed document to operationalize the study procedure with a detailed description of each step of the study and execution process. During the life cycle of the study it also needs the updates to the study based on the information generated during the trial process. As an integral part of the clinical trial process the stakeholders take pride in publishing the newsletters to provide crucial information about all the activities related to the clinical trial. The skilled professional at our organization provide exceptional support in drafting the study procedure manuals to meet the study conduct requirements. The meticulous proficiency by the team members ensures to provide periodic updates to the study. We also have experts to work on the newsletters in a language that is read and understood by all to convey all the relevant details of the clinical trial to the relevant audience.

A clinical study report provides a clinical and statistical depictions, presentations, and analysis of the complete study. This reports basically include a detailed description of the critical design features, planning, methods involved, individual patient details, details of analytical methods and conduct of the study. It is an important document to describe the study endpoints by detailing the data collection and the procedures involved in data analysis which confirms the achieved study end points. The document is designed in compliance to the ICH E3 guidelines. We provide adept solutions with cross functional subject matter experts who can support you to design the clinical study report as per the guidelines. The team shall ensure the completion of the clinical study document within 15 days of the assignment. We also ensure multiple levels of quality review by experts to ensure the accuracy of the documentation.

An abstract preparation is a concise presentation of the study which summarizes the major aspects of the study in a paragraph. It acts as a preview to understand the case study. The manuscripts are presented sequentially in four sections to include introduction, methods, results and discussion. The abstract is an overview of the manuscript of case study. Case studies are designed to gather information on actual trial subject encounters which is treated as real time data. They are the effective tool in demonstrating the clinical decision making of the study drug. They are commonly used in social, educational and clinical research. The case study involves qualitative methodology to describe the safety and efficacy of the study drug. The research scientist team provides immense support in preparation of precise abstracts, manuscripts and case studies for various therapeutic segments within the specified timelines.

It is imperative to consider and adapt the opinions of the leaders involved in the study design. The procedure involves to record all the details and recommendation made by the leader for a study design. Documentation and collection of the data play a key role to be considered during the study design. They lay the foundation to success of a clinical trial. Critical data points like study objective, environment of the study and the disease under investigation plays a vital role during the design in compliance to the regulatory guidelines. At our organization, we provide custom made solutions to meet the study objective and help in designing the study. We also provide support in collection and analysis of the key opinions provided by various leaders and provide a consolidated report in the clinical decision making of the study drug.