Medical Writing
It is difficult to overestimate the importance of medical writing for the overall success of clinical trials and non-interventional studies / observational programs.
ALMEDIS medical writers, working in close collaboration with our biostatisticians, possess both vast industry knowledge and experience in a broad range of therapeutic areas.

Medical writing services provided by ALMEDIS:
  • Scientific Study Concept development
  • Study Protocol writing
  • Patient Information and Informed Consent Form development in accordance with ICH GCP requirements and local regulations
  • Study Report writing for clinical trials and non-interventional studies
  • Publication preparation for local and international journals

Since 2006 ALMEDIS has managed more than 80 writing projects for our clients in different therapeutic areas.
ALMEDIS also has experience in the preparation of pharmacovigilance system documents and documents for the product registration dossier, in accordance with the current requirements of the EAEU.

Operational Project Management
Our CRO provides the full package of services for allocation, management and execution of clinical trials and non-interventional studies. We use the wide scope of opportunities offered by the Russian market of clinical trials and advanced experience of our team.

We offer our clients the following services in any combination required.
Learn more about services in the field of research management:
Study feasibility
Feasibility analysis in our CRO consists of the following essential components:
  • Overall study acceptability from regulatory / ethical standpoints
  • Access to a target patient population
  • Existing patterns of care and their compatibility with a proposed study design
  • Access to experienced and motivated clinical sites
  • Potential patient enrollment per site
  • Availability of the necessary facilities / equipment / lab tests / concomitant medications
  • Study appeal for potential investigators
  • Influence of ongoing or planned competing studies
  • Identification of other potential risks, challenges and bottlenecks
  • Contingency planning
Site selection
We possess our own large database of clinical sites with experienced and motivated investigators in more than 50 cities of Russia, e.g.:
  • More than 50 oncology sites
  • More than 50 neurology sites
  • More than 30 endocrinology sites
  • More than 60 cardiology sites
  • More than 20 surgery sites
  • More than 20 hepatology sites
List of prospective clinical sites is discussed and agreed upon with a study sponsor.
Clinical trial dossier preparation and application to Health Authorities
The timelines for obtaining clinical trial approval by the Ministry of Health of Russia are monitored by ACTO and are regularly published.

For non-interventional studies in the Russian Federation, which do not require approval from the Ministry of Health of Russia, ALMEDIS provides submission to the umbrella ethics committee.
Investigators meeting preparation and conduct
ALMEDIS has successfully conducted more than 50 investigators meetings in Russia and abroad, involving in total more than 1200 participants
Project management
Each of our project managers has at least 8 years of experience in Clinical Operations. ALMEDIS project manager is assigned to every project at the time of the project initiation and stays responsible for it until all study activities are completed
Monitoring is one of the key elements of an integrated approach to ensuring high-quality clinical trial data and proper subject protection. Types (e.g. on-site monitoring, centralized monitoring), intensity, frequency and scope of monitoring activities for a given trial are determined and agreed upon with a sponsor prior to the trial initiation, based on its objectives, design and complexity. These monitoring requirements are reflected in a monitoring plan.

Adaptive monitoring approach

Nowadays clinical trials and even non-interventional studies are so different in design, goals, complexity, scope and scale that no single methodology of monitoring can fit them all. Risk-based Monitoring is a customized, quality- and risk-based approach that focuses on the parameters, which are critical for a specific study. It is a mix of centralized and on-site monitoring activities providing a cost- and time-effective way to ensure patient safety, proper quality of a study conduct and study data integrity.

In 2013 Food and Drug Administration (FDA) issued “Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring”, and the European Medicines Agency (EMA) released “Reflection paper on risk based quality management in clinical trials”. These guidelines provide the regulatory perspective and rationale for risk-based monitoring strategies, but they do not mandate specific implementation methods.

Our contract research organization can suggest its local and international clients unique proposition of well-balanced customized risk-based monitoring solutions for their local clinical trials and non-interventional studies. Combination of in-house Data Management, Programming, Biostatistics and Monitoring resources enables us to create strategies of risk-based monitoring which allow real-time proactive study risk assessment. Real-time e-CRF data collection and analysis provides basis for early detection of protocol deviations, adverse events, missing/inconsistent data, other site-specific issues, understanding of patient data trends.

Based on the needs of our customers we can:
  • Develop study-specific Key Risk Indicators (KRIs) to trigger fast detection and interpretation / further escalation of risk signals
  • Develop study-specific Monitoring Plan tailored to the identified study-specific risks and based on the monitoring strategy selected
  • Select study sites taking in account quality of their performance in previous studies with ALMEDIS
  • Perform in a real time mode in-house central/remote monitoring of study data
  • Conduct central analysis of site performance/compliance
  • Adjust quantity, focus and timing of contacts with sites and on-site monitoring visits based on centralized monitoring results to ensure proper site performance and data quality
  • Develop and implement corrective/follow-up actions based on the monitoring findings in order to ensure patient protection and data integrity

Risk-based Monitoring approach offered by ALMEDIS to our clients implies significant quality and productivity advantages along with potential cost reduction.
Site management
We value and respect the investigators with whom we work in projects, and we pay special attention to ensuring that they always have the necessary support from our side. Site management in ALMEDIS is an essential multi-stage process which includes but not limited to:
  • Site contracts negotiation
  • Support to sites in local Ethics Committee submissions
  • Site training on study protocol and ICH GCP, preparation of training materials
  • Ongoing contact of ALMEDIS project team with the investigators
  • Providing sites with regular study updates
  • Ensuring Investigator Folder / Trial Master File integrity
Clinical trial medication and clinical trial supplies management
Upon a request from a clinical trial sponsor, ALMEDIS can ensure purchase, labeling, distribution, delivery to/from sites, accountability, storage and destruction of different kinds of clinical trial materials, including clinical trial medication, concomitant medication, etc.
Data Management
Our Data Management specialists are professionals with 8 to 20 years of individual experience, gained in the top-tier international CROs and scientific institutions.

Our contract research organization provides full scope of Data Management services:
  • Case Report Form design (CRF/eCRF) in Russian or in English
  • Database design and testing
  • Data Management documents preparation (including DMP etc.)
  • Data entry and validation (for paper CRF)
  • Data import (e.g., from a Central Laboratory)
  • Data Query generation and resolution
  • Medical coding by MedDRA and WhoDrug
  • SAE reconciliation
  • Database quality control (for paper CRF)

Since 2008, we have been working with the Clinical Data Management System (CDMS) of Ennov, a leading international Life Sciences technology provider.Ennov Clinical CDMS complies with international standards (including CDISC, ICH, BPC 2001/20 / EC) and requirements.In our practice, it has successfully used in more than 70 projects (clinical trials and observational studies.


Our biostatisticians are seasoned professionals with 10 to 25 years of individual experience in clinical research, able to create and to apply an accurate, well-balanced blend of math and medicine to every project.

In the field of biostatistics we offer the following services:
  • Statistical considerations of study design
  • Sample size calculation/justification
  • Randomization
  • Statistical Analysis Plan (SAP)
  • Programming of analysis datasets, tables, listings and figures
  • Data transfers
  • Statistical reports
Statistical analysis is performed with SAS® software. In Russia Almedis was the first SAS local subscriber for clinical trials (see SAS web-page for more information).
Statistical analysis (SA) procedures comply with ICH Statistical Principles for Clinical Trials.

SA is run in accordance with relevant SOPs, Study Protocol, SAP and results in a Statistical Report.

Independent double programming is the main quality control tool.
Based on the statistical analysis we can prepare a comprehensive clinical report on the study results.

ALMEDIS is also an SPSS subscriber and has experience with R language.

For local staff of our corporate clients (Clinical Operations, Medical Affairs, Marketing) and investigators ALMEDIS provides tailored trainings in such relevant topics as:
  • ICH GCP-related topics
  • Pediatric Clinical Trials
  • Statistical aspects of clinical studies
  • Overview of Data Management (DM) processes in clinical and non-interventional studies
  • Using of PRO and health measurement scales in clinical trials
  • Non-interventional studies: overview and practical aspects
  • Real world data studies
  • Organization and regulatory support of investigator-initiated studies
  • Planning and setting goals in scientific medical research

In 2018 ALMEDIS in collaboration with the Institute of Laboratory Medicine launched the Clinical Research Department for conduction of trainings in clinical research. Successful accomplishment of training programs by investigators is confirmed by a state education certificate.