Regulatory Writing

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.

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

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

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

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!