Smooth Drug Development provides services in medical documents development.
Study design and documentation development is crucial both for obtaining of clinical trial approvals and collecting of relevant data during the study, which later determines further development and possibility of obtaining of Marketing Approval for the product.
Our specialists have extensive experience in planning and preparation of documents for phase I-IV clinical trials: bioequivalence, non-inferiority, biosimilar and novel drug studies. Proper preparation of study documentation is largely due to our experience in development of final clinical study reports.
Since 2011 our specialists have developed more than 140 packages of clinical research documents. The company is proud that since that time we have not received any rejection from regulatory bodies. Most of these studies have been successfully completed as planned.
Our medical writers and biostatisticians provide the following services:
- Literature review of preclinical studies
- Preparation of clinical development program
- Expertise of clinical trial documentation
- Development of clinical study protocol synopsis with sample size calculation
- Development of clinical study protocol
- Preparation of Investigator's brochure
- Preparation of subject information sheet with informed consent form
- Development of subject's diaries and questionnaires for data collection
- Replies to regulatory authorities requests on submitted documents
- Articles and reviews
The company's specialists are working in accordance with local and international standards, GCP requirements, EMA, FDA and the company's SOPs. To make sure that our concepts meet the most current treatment standards, we collaborate with Key opinion leaders in different nosologies, in which studies are to be conducted.
Our employees regularly pass trainings and participate in seminars conducted by regulatory bodies, which helps us to consider current and even future requirements.
When it is scientifically justified, our specialists will offer adaptive clinical trial design that enables us to minimize sample size and number of treatment groups, shorten study timelines and decrease study cost as a result.
Clinical trial with adaptive design – is a study with pre-determined possibility to modify one or more elements of study design based on the interim study results, such as inclusion criteria, randomization procedure, treatment regimens in different therapeutic groups, sample size, concomitant therapy, schedule of research procedures, final endpoints and methods of statistical analysis. The most common examples of such studies: combined phase II-III studies and a recalculation of sample size on the results of the interim analysis.
If necessary, our specialists will perform translation of documents. Our translators undergo a thorough selection and have necessary diplomas and certificates. We offer two main options for translations QC:
- Two-step verification (proofreading)