Regulatory and
Medical Writing Service

Creating high-impact content is both art & science. We write engaging and informative content that sets your brand apart. From Medical to Tech, Articles to White papers, and across multiple industries, ADI has extensive writing expertise. Our writers use a data-centric methodology to write content which is not purely opinion but also backed by supported factual data. This approach is significantly powerful for long term content writing projects needed by digital and content marketing strategists. ADI’s in-house training program to support our writer’s ability to produce documents with clear, concise, consistent and completeness.

Expertise

  • Medical Writing:
  • Regulatory and Clinical Report Writing
  • Clinical trial protocols, evaluation Report & study report appendices
  • Case report forms & Investigator Brochures
  • Package inserts and Patient Information Reports (PIRs)
  • Clinical Development plans
  • Common Technical Document (CTD)
  • Site-specific and Country-specific reports
  • Content Marketing:
  • Web content
  • Blog writing and guest posts
  • Informational articles
  • Press releases
  • White paper
  • Newsletter

Protocol Design

Protocol design is one of the essentials develop the fundamentals for your project. Our solutions and services are designed in order to provide an accurate and the tailored designed protocol to ensure the progress in the clinical phase of drug development. Our Protocol Design specialists can help with:

  • Protocol conceptualization
  • Study laboratory manuals
  • Comprehensive sub-study protocol design
  • Informed consent form design and patient brochures
  • Case report form design
  • Documents available in multiple languages

CRS

Magnify the effect of your clinical study report and increase your chances of FDA approval. The CSR’s we formulate are fully optimized and well-organized for the best written CTD’s. Patient criterion and individual clinical trials patient data. All aspects of treatments administered including dose, timings, treatment compliance, a method of assigning treatment groups and bindings. Efficacy and safety variables and data collected from the trials. Data quality assurance and statistical methods for the perfect determination of sample size. Conversion in the conduct of the study or planned analysis. Demographically presented information.

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!

Standard Operating Procedure Development (SOP)

Our SOP solution approach is to develop bespoke plans for your clinical operations, monitoring, feasibility, and project management, which enables us to identify the crucial areas.

  • GCP training
  • Informed Consent Process and Documentation
  • 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

Case Report Form Design Solution

Our Clinical Data Handlers brings in the use of their experience for your project, and design case report forms which both support and enhances the process of how you record data for your projects.

The form that we provide adheres to the following standards:

  • 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 Narratives

The issues are extracted as a patient’s narrative will be put across in a way so that you, as an existing or an upcoming stakeholder in the concerned disease/medical condition, can draw considerable meaningful insight for the same. These narratives are sure to add momentum to the current state of development so that you can deliver better diagnosis and devise better solutions.