REGULATORY WRITING

You do not want your hard work undone at the final hurdle!

Maximize the effectiveness of your clinical study report and increase your chances of FDA approval.

Highly Skilled Team

Professional Clinical Study Reporting, Patient criterion, Efficacy and Safety Variables

Raw data is a stack of highly meaningful information, provided one is equipped with the exact means to valuable outcome, your clinical trials report must address complicated criteria and achieve very high standards. We are a medical writing agency that will take care of this crucial task, presenting the report in compliance with regulatory body requirements.

Clinical Study Report (CSR)

It is not enough to be able to collect and group data, you have to be able to identify specifics and analyze the data.
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Standard Operating Procedure Development (SOP)

Our SOP solution approach is to develop bespoke plans which take…

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Case Report Form (CRF) Design Solution

Our Clinical Data Handlers bring their fifteen years of experience to your project…

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Patient Safety Narratives (PSN)

We can compile reports based on your brief. This includes patient selection data, specific drug information,

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Protocol Design

Protocol conceptualization, design, and preparation in compliance with ICH-GCP guidelines

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Bibliography Search

We firmly believe in the value of excellent bibliographic searches as one of the foundations of good regulatory submissions and clear argumentation to support filings.

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WE WOULD LOVE TO WORK WITH YOU

Why ADI Intellect

ADI Intellect’s professional solutions ensure that your projects are developed faster and with precision. The development of documentation and protocols is extremely important, and our more than 30 Years of experience in the field has given us the insight to develop these more accurately, making us one of the leading regulatory writing companies in India. We are thoroughly committed to freeing up your time to concentrate on other important aspects of your clinical trials and drug development projects.

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Our Benefits

Quality

At ADI Intellect, QUALITY bespeaks our commitment to the highest standards. We believe that excellence is an attitude. Aiming for 100% is deeply rooted in our culture. You can be sure that all the work we produce for you will be precise and accurate.

ADI Intellect is an ISO 9001:2008 certified company and all our departments diligently implement its quality check and improvement mechanisms. At ADI Intellect all errors and their causes are well documented to ensure that every error adds to the development of a world-class quality system.

Delivery

Our services are geared to meet the deadlines you set. Transfer the burden to us. Our years of experience in meeting deadlines have been developed using backup and redundancy systems to compensate for delays.

Our backup strategy secures your deadline. We audit our processes to ensure that Plan B kicks in should Plan A fall short of your requirements. We always deliver on-time and have maintained our Zero Default record for over fifteen years.

Some of our Happy Clients

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Clinical Study Report (CSR)

The content of CSR is detailed in the ICH guideline E3. A CSR provides an explanation of the critical design features, methodology, statistical and clinical description, individual patient data, and analysis of the completed study. ADI Intellect follows the guidelines including synoptic, abbreviated and full submission reports, and we make sure that each aspect is covered to the detail.
Overall study design and description
Control groups used
Patient criterion and individual clinical trial patient data
All aspects of treatment administered including dose and timings, treatment compliance, method of assigning treatment groups and blinding
Efficacy and safety variables and data collected from the trials
Data quality assurance and statistical methods used in the protocol and determination of sample size
Changes in the conduct of the study or planned analysis that occurred during the clinical trials
Adverse Events and Serious Adverse Events Reporting
Information presented in tables, graphs, figures, flowcharts, and text in line with regulatory body requirements

Standard Operating Procedure Development (SOP)

At ADI Intellect, Our SOP solution approach is to develop bespoke plans which take the development and revision of procedures by applying document standards, criteria and adhering to timelines.
GCP training
e-learning for GMP
Subject screening and recruitment
Informed Consent Process and Documentation
Eligibility confirmation
Source documentation
Data management
Protocol deviations
Confidentiality of Information
Drug/Device Storage, Accountability and Management
Regulatory Document Submission Process (Initial Submissions, Amendments and Continuing Reviews)
Sponsor, CRO and Internal Audits
FDA audits

Case Report Form (CRF) Design Solution

ADI Intellect makes sure the CRFs are study protocol-driven, content-rich and have essentials to collect the study-specific data. Our Clinical Data Handlers bring their fifteen years of experience to your projects to help you with paper CRFs as well as electronic CRFs (eCRFS) as latter is gaining popularity due to its advantages like improved data quality, online discrepancy management, and faster database lock, etc.
Collect data relevant to the specified protocol
The CRF design process is fully documented including approvals and version control
The CRF will be available at a specified clinical site prior to the enrolment of a subject

Patient Safety Narratives (PSN)

ADI Intellect produce consistent, high-quality PSNs without unnecessary increases in cost and threats to timelines. Patient safety narrative (PSN) is an essential part of the CSR and pharmacovigilance, which provides the relevant brief information to describe the adverse events experienced by the patients during the clinical trial.
Regulatory review perspective
Narrative content format
Sources
Review cycles
Quality Calibration
Medical/clinical input

Protocol Design

Protocol design is essential to develop the fundamental for your project. Our Protocol Design specialists can help you with:
Protocol conceptualization, design, and preparation in compliance with ICH-GCP guidelines
Study laboratory manuals to accompany the clinical protocol
Comprehensive sub-study protocol design and implementation
Informed consent form design and patient brochures
Documents available in English or French

Bibliography Search

We firmly believe in the value of excellent bibliographic searches as one of the foundations of good regulatory submissions and clear argumentation to support filings. Our dedicated teams of bibliographical investigators gather relevant information and place each individual search through an intensive data-filtration process. Good pursuits are indeed demanding and time-consuming for all, except for the experts!