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.

Standard Operating Procedure Development (SOP)

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

Case Report Form Design Solution

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

Patient Narratives

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

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 faster and 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.

Protocol Design

    • 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
    • Case report form design
    • Documents available in English or French

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CSR (Clinical Study Report)

      • Overall study design and description
      • Control groups used
      • Patient criterion and individual clinical trials patient data
      • All aspects of treatments administered including dose and timings, treatment compliance, method of assigning treatment groups and bindings
      • 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
      • Information presented in tables, graphs, figures, flowcharts and text in line with regulatory body requirements
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Bibliographical Searches

At ADI Intellect, 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 team of bibliographical researchers gathers relevant information from a multitude of subject areas, putting each individual search through an intensive data-filtration process. The researchers then condense expertly selected information into succinct, reviewer-friendly summaries. Good searches are indeed demanding and time-consuming for all, except for the experts! So let our clinical data team of bibliographical search specialists take over this responsibility while you utilize your time to assure more rapid drug development.

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Standard Operating Procedure Development (SOP)

      • GCP training
      • e-learning for GMP
      • Subject screening and recruitment
      • Informed Consent Process and Documentation
      • Eligibility confirmation
      • Source documentation
      • Data management
      • Protocol deviations
      • Adverse Events and Serious Adverse Events Reporting
      • 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
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Case Report Form Design Solution

        • 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

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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. Of course, errors happen, but they are part of our learning process and only strengthen our resolve to never make the same mistake twice. As a result, 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 has 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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