Sciencefiles is a unique new company that provides services to the pharmaceutical industry in Russia. We are the first company in the Russian Federation that exclusively specializes in medical writing and data analysis for clinical trials for both pharmaceutical products and medical devices, thus ensuring high-quality service.
Sciencefiles facilitates the preparation of key documents for registration of Phase I through IV clinical trials for both pharmaceutical products and medical devices and in various therapeutic areas.Our services include:
- Clinical trial protocol development
- Development of patient information leaflets and informed consent forms
- Creation of Clinical Investigator’s Brochures (with optional development of nonclinical and/or clinical study reviews)
- Review of already prepared protocols or any other essential documents (with optional preparing amendments in accordance with a regulatory authority’s comments)
- Literature review and summary of nonclinical and clinical studies in the Common Technical Document format (CTD format)
- Risk management plan development for pharmacovigilance
Sciencefiles specialists have profound knowledge and expertise in scientific medical writing. We can prepare the following scientific or medical marketing texts:
- Research articles
- Review articles
- Systematic reviews
- Healthcare provider information materials
- Patient information materials
- Development of data management plans
- Creation of patient diaries
- CRF annotation
- Database description/development
- Development of paper/electronic case report forms (CRF/eCRF)
- Database creation
- Training of data entry specialists
- Development of database entry guidelines
- Incoming control of paper CRFs
- Data entry by one or two data entry specialists
- Quality control of databases
- Development of data validation plans
- Validation of data in the database
- Encoding of database data
- Data query assignment
- Data extraction from databases
- CRF storage
- Checking for completeness of a CRF before its return
- CRF destruction
Biostatistics is the area in which Sciencefiles specialists have many years of experience in clinical trial data analysis.We offer the following services:
- Sample size determination
- Generation and/or formatting of randomization tables for envelopes or IxRS
- Statistical analysis plan development
- Statistical analysis plan review
- Statistical analysis with generation of a statistical report
- Final study report compilation
- Universality and High Competence
- Right on Time
- Guaranteed Results
- Easy Interaction
- Reasonable Prices
Universality and High Competence
Sciencefiles’ wide and diverse experience and the professional skills of our employees allow us to solve problems of any degree of complexity, in particular, creating documentation and analyzing clinical trial data for any trial phase (I through IV) and in all therapeutic areas.
The Sciencefiles team today comprises physicians of diverse specialties, clinical pharmacologists, medical advisors and liaisons, clinical research specialists with strong expertise in clinical trial conduct, biostatisticians, as well as data managers and data entry clerks.
Our vast experience in clinical and scientific documentation development and data analysis is comparable to the experience of large contract research organizations, yet our prices are lower.
Right on Time
Short timelines are our main priority. Sciencefiles employees’ compensation is based on the operational efficiency and key performance indicators for meeting the key project deliverables.
Our vast experience based on hundreds of completed projects along with constantly updated and improved templates, algorithms, and detailed SOPs facilitate the process of medical writing and data analysis and ensure timely project completion.
Regardless of the complexity of the task and the amount of data to be analyzed, Sciencefiles specialists deliver high-quality results right on time.
Clinical trial documentation that we develop, starting from the trial concept and ending with the complete clinical study report, conforms to regulatory agency standards and expectations. We comply closely with the changes in all applicable local and international clinical trial legislation and guidelines, and regularly train our employees.
We provide free medical monitoring services at all stages of a clinical trial for trials based on documents developed by Sciencefiles. In this way, we can guarantee that the trial is conducted properly and in accordance with the original scientific concept; this also guarantees a timely and adequate solution of any medical issues that may arise during the study.
We use only professional statistical software packages delivering high-quality results with maximum productivity.
We guarantee privacy of any data exchange between Sciencefiles and our clients (SSL security protocol is used for all data transfers).
Projects from the same client are managed by the same Sciencefiles employee who has knowledge of previous projects as well as the client’s preferences.
“Virtual Office” – the electronic project management system developed exclusively for our company – makes project management extremely easy and efficient, both in terms of interaction between the client and Sciencefiles team and document or data exchange.
Unlimited teleconferences are included for each project, allowing the client to stay up-to-date and to stay in touch with the project team.
“Virtual Office” and teleconferences allow us to work remotely with any client regardless of physical location (both in Russia and abroad) as well as to keep our clients updated on the progress of the project.
Working with Sciencefiles allows you to plan your budget in advance (including participation in various projects), because the maximum cost of every service is fixed at the time of the initial request.
Our service costs are quite modest, especially given that our cumulative experience in medical writing, data management, and data analysis are comparable to the experience of large contract research organizations.
We will match our competitors’ prices. All you have to do is provide information about any services at another company that cost less and are comparable to our services, and you will receive a discount.
Any Document Type
Ipsen is driven by a passion to improve the lives of patients. A search for innovative solutions to disabling conditions is at the heart of everything they do. They are inspired to find effective therapeutic options to treat diseases, relieve suffering, and bring value to the community.