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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.

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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 Investigators 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 authoritys 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
  • Meta-analyses
  • Healthcare provider information materials
  • Patient information materials

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Sciencefiles specialists facilitate the following data management tasks:
  • 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
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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
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Your Benefit

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.

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Instant Project Start

Self-registration for the Virtual Office user account allows our clients to create projects minutes after the first visit to our site.

Once the project is created, our specialists can be contacted promptly and directly to initiate discussion and project setup.

A scanned Letter of Commitment is all you need to get started with activities for your project at Sciencefiles.

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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.

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Guaranteed Results

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).

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Easy Interaction

Projects from the same client are managed by the same Sciencefiles employee who has knowledge of previous projects as well as the clients 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.

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Postpaid

Prepayment is not required at Sciencefiles; therefore, you can pay after the actual work is done and the results are tangible.

We accept bank payments in Russian rubles and in US dollars.

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Reasonable Prices

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.

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Our Expertise
As of 1st of April 2017

Facts

completed projects
clinical trials
clients
years experience

Any Document Type

Any Therapeutic Area



Clients & Testimonials
Bayer is a Life Science company with a more than 150-year history and core competencies in the areas of health care and agriculture.
Pharm-Sintez is among the top Russian pharmaceutical companies. It has been operating a complete production cycle since 1997 from the synthesis of active molecules to the output of drug products. The companys medicines have been applied for many years in oncology, oncourology, surgery, gastroenterology, gynecology, endocrinology, emergency medicine and radioisotope diagnostics and proved safe ad highly effective.
Vertex - Russian pharmaceutical company operating in the market for more than ten years.
Petrovax Pharm develops and produces innovative medicines and vaccines to help improve peoples health and quality of life.
Founded in 1997, Pharmasyntez is today the largest Russian producer of anti-TB drugs. Since 2002 it have been one of the top twenty pharmaceutical companies in Russia by the volume of production.
Valenta Pharm, JSC, is the Russian pharmaceutical company established in 1997. The Company is ranked the 2nd among Russian pharmaceutical companies. Valenta develops, produces and promotes Rx and OTC/OTX products in main therapeutic areas: psychoneurology, urology, gastroenterology, immunology, virusology, antibacterial therapy and others.

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.

Worldwide Clinical Trials is a global contract research organization that provides full-service drug development services to the pharmaceutical and biotechnology industries. One of the most innovative and scientifically-driven contract research organizations.
Synergy Research Group - a leading Russian contract research organization, successfully operating throughout Russia and the CIS countries since 2002.
Cromos Pharma is a contract research organization (CRO) that specializes in biopharmaceutical clinical outsourcing to Russia, Ukraine, Georgia and the countries of Eastern Europe areas with the most compelling environment for biopharmaceutical research. They manage Phase I-IV clinical trials, bioequivalence and observational studies. The company has been successfully operating since 2004.
Since 2003 INVITRO acts as a Central laboratory for more than 300 Russian and International clinical trials. INVITRO has its own department of clinical trials. Since January 2013 Independent laboratory INVITRO provides a full complex of services in organization and conduction of clinical trials.
MatrixPharm is an independent contract research organization (CRO) which provides a full range of clinical studies services (Phases II IV) in Russia and the countries of the CIS, for pharmaceutical and biotechnology companies worldwide.
Evalar - one of the largest Russian pharmaceutical companies, the absolute leader in the country in terms of release of natural products for health protection and promotion.
AstraZeneca is a global, science-led biopharmaceutical business and it's innovative medicines are used by millions of patients worldwide
R-Pharm is a Russian private hi-tech pharmaceutical company founded in 2001. The company is involved in R&D, manufacturing, marketing, sales and distribution of innovative pharmaceutical products from a broad number of therapeutic areas in specialty/hospital care.
AVVA RUS is a pharmaceutical company which, as well as the Swiss company AVVA Pharmaceuticals AG, belongs to the pharmaceutical group. Thr priority area of the group activity is to develop original products possessing unique safety profile for the patients.
R&DPharma is a russian-based contract research organization specializing in conduction of local pre-clinical, clinical studies and registration of medicinal products in Russian Federation. R&DPharma was founded in 2009 and since than we have gained a strong position in the field of research and development aiming registration of medicinal products.
Pharmaceutical company OBL Pharm was founded in September 1994 at the State Research Center for Applied Microbiology. The product portfolio of the combined company has more than 100 medicines
The National Agency for Clinical Pharmacology and Pharmacy (NACPP) created the community of the leading Russian experts in the field of laboratory and clinical studies. The company accompanies all phases of clinical trials and studies the pharmacokinetic properties of drugs and bioequivalence.
Institute of Immunology - the leading scientific and medical institution of the country in the field of immunology and allergy and one of the leading centers for the prevention and control of AIDS. Research conducted at the Institute, aimed at creating innovative products aimed at the achievement of strategic national priorities of Russia
Over 30 clients more

News & Events

Data analysis for February 2017 showed a small increase in number of approved clinical trials compared with the last month and decrease compared with the same period in 2016.

Data analysis for January 2017 showed a decrease in number of approved clinical trials compared with the last month and with the same period in 2016

Data analysis for December 2016 showed a small increase in number of approved clinical trials compared with the last month and an expressed decrease compared with the same period in 2015.

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Contact Us
Phone:+7 (343) 344-33-87 
Office 102, 8, Parnikovaya str., Ekaterinburg, 620135, Russia
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