Our professional solutions ensure that your projects are developed faster and with precision. The development of documentation and protocols is extremely important, and our fifteen year 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.
Medical writers at Magnentum are fully conversant in crucial regulatory guidelines, including the International Conference on Harmonization (ICH). The final document thus delivered to you is compelling, the best possible case for your product. With the likes of FDA Reviewers, study investigators and staff as your primary audience, this is just what you need to significantly increase your chances for both trial and marketing approval and acceptance by global health authorities.
Our medical writing expertise entails:
Regulatory and Clinical Report writing in compliance with ICH E3 guidelines/applicable regulatory submission
Clinical study report appendices
Clinical trial protocols
Case report forms
Investigator Brochures briefing packages for meetings with health authorities
Package inserts and patient information reports (PIRs)
Clinical development plans
Top-line results reports
Informed consent forms
Pharmacovigilance documents like annual safety reports
Periodic adverse drug experience reports (PADER)
Patient safety narratives
Common Technical Document (CTD)
Clinical Evaluation Report (CER) for medical devices
Site-specific and country-specific reports
ICH-compliant summaries on drug, device and biologic marketing applications
More than fifteen years of offering these services has helped us hone every necessary skill, leading us to make a mark as a premium ICH Medical Writing company in India.
Outsource protocol design for us to ensure success and speed!
Protocol design development for your clinical trials is fundamental in development of the project. Our services have been designed with this in mind and provide an accurate and bespoke designed protocol to ensure the progress into the clinical phase of drug development runs smoothly. Our Protocol Design specialists can help 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
- Case report form design
- Documents available in English or French
Moreover, our knowledge of clinical pharmacology ensures an easy transition to your first Phase 1 clinical study and to subsequent PK/PD studies.
CSR (Clinical Study Report)
Maximize the effectiveness of your clinical study report and increase your chances of FDA approval. You do not want your hard work undone at the final hurdle!
Our professional clinical study reporting includes, but is not limited to the following:
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
Your clinical trials report has to meet a complicated criterion and ascertain certain standards. We are a medical writing agency that can take care of this stressful aspect, presenting the report in accordance with regulatory body requirements.
At Adicro, 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 gather 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.
Standard Operating Procedure Development (SOP)
Our SOP solution approach is to develop bespoke plans which take into account your clinical operations, clinical monitoring, feasibility, and project management. This enables us to identify the crucial areas and build from that point.
With a SOP developed in a timely fashion, your projects get underway faster and more easily directed as you have a tangible SOP for quality pharmaceutical from the outset.
Typical SOP development projects include but are not limited to:
- 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
Using our SOP Development solution you will have a basis to move your project forward faster, as your teams will be better informed and directed.
Case Report Form Design Solution
Our Clinical Data Handlers bring their fifteen years of experience to your project, and design case report forms which both support and enhance how you record data for your projects. At all times, any form we provide will adhere 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
These offer thorough analysis of pre and post-market clinical data in relevance to the intended use. The issues elicited as a patient narrative will be put across in a way so that you, as an existing or upcoming stakeholder in the concerned disease/medical condition, can draw considerable meaningful insight on 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.