Regulatory and Medical Writing Service
Our professional’s ensures to develop your projects faster with precision. The development of documentation and protocols are exceptionally dominant, and our pertinent experience in the field of medical writing has given us the insight to build your projects more swiftly, thus making us one of the paramount regulatory writing companies in India. We are thoroughly committed in providing you with the best solutions.
Medical writers at ADI-Group are thoroughly acquainted in crucial regulatory guidelines, including the International Conference on Harmonization (ICH). With the likes of FDA Reviewers, study investigators and the staff as your primary audience, this is exactly what you require to enhance your chances for both trial and marketing approval acceptance by global health authorities.
- Regulatory and Clinical Report Writing
- Clinical study report appendices
- Clinical trial protocols
- Case report forms
- Investigator Brochures
- Package inserts and Patient Information Reports (PIRs)
- Clinical Development plans
- Informed Consent forms
- Patient safety narratives
- Common Technical Document (CTD)
- Clinical Evaluation Report (CER)
- Site-specific and Country-specific reports
Protocol design is essential to develop the fundamental for your project. Our solutions and services are designed in the same manner, keeping in mind to provide an accurate and the bespoke designed protocol to ensure the progress into 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
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
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
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.