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    Ascent CRS is a full-service CRO that provides an entire range of clinical research services from Phase I and Proof of Concept to Phase III-IV and Bioequivalence studies.

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WHAT WE OFFER

We are a full-service CRO providing all the services that any clinical trial may require.

Regulatory affairs

Thanks to our local presence, we are able to master all country local regulations, guiding you through all the local specific aspects.
In order to optimize the timelines, we have regulatory managers, dedicated to preparing submission files and establishing privileged relationships with Competent Authorities.

As for the export &import of the investigative product, biologic samples and medical equipment, we've established a reliable network of vendors (local depots, agents, custom clearance, couriers) in order to timely and accurately facilitate this activities.
We have developed and we maintain on a continuous basis, local SOPs on regulatory submissions and import management.

We have extensive experience in managing all aspects of regulatory affairs, supporting a product from the drug development phase throughout all phases of clinical development.

We provide expert regulatory services to our all our clients and work in consultation with them to develop customized regulatory strategies and expedite the regulatory review & approval process.

We keep close contact with the regulatory bodies, as they request solid scientific data and thoroughly developed protocols.
Our regulatory team will provide you with a deep industry knowledge and hands-on experience in working with competent authorities.

From the beginning of your project to its completion our regulatory affairs team will provide overall regulatory support for your clinical trial as a part of our comprehensive clinical study management services.

We create and review your study documents, such as study protocols, drug labels, patient informed consent forms and information sheets, to make sure they have been prepared according to all applicable laws and regulations in the corresponding country.

We provide the following regulatory services:

• Phase I-IV Clinical Trial Applications preparation, submission and management
Import licenses for investigational products, ancillary supplies and equipments
Export licenses for investigative product, biologic samples and medical equipment
Site and product registrations for drugs and devices
• Processing subject insurance and also local insurance policies
• Ongoing interaction with regulatory authorities, Ethics Committees and other competent regulatory authorities
• Certified translations and back-translations of documents into applicable languages and proofreading by native speakers
• Processing of protocol amendments and revisions to patient informed consent forms and information sheets

With the help of experienced, full time clinical research coordinators we help the investigators with all the ethical committee submissions, documentation and safety reporting following strict timelines.

We also arrange various regulatory trainings for Sponsors and CROs.

Russian Law on "Circulation of Medicines"

Georgian Law on "Drugs and Pharmaceutical Activity"

Clinical Conduct

Being CRO combined with an SMO we provide our partners with extensive site management experience and professional conduct of a clinical part of any study.

Having our own medical team with day-to-day medical practice on-board we can conduct any early phase study with an exceptional understanding and quality. This also helps us eliminating the gap between sites and sponsor / CRO in accelerating patient enrollment and effectively managing the trial from start to finish; thus ensuring smooth transit of the trials to the next phase.

All members of our team timely receive internal trainings, are ICH-GCP certified and have a day-to-day on-going medical practice with patients.

Our team has existing relationships with Academic Medical Centers and hospital-based research centers in Russia and Georgia. Pre-existing relationships result in expedited study start-up, including regulatory tasks and approvals, contracting, and site initiations.
We also routinely assist in site selection, picking sites that have the highest likelihood of recruiting the necessary patients, with the help of our large internal database of potential investigators/sites in our focused therapeutic areas around the world.

We have an exclusive agreement with Centre of Applied Clinical Pharmacology, that initiates & develops Phase I/II clinical trials in Russia and CIS countries.

CACP Investigators were among the first Russian academic groups to start running clinical studies Phase II-III in Russia for international companies in the early 90s and have contributed to more than 1000 trials in various therapeutic areas since that time. Investigators team consists of MDs and PhDs with more than 20 years of experience in clinical trials and on-going day-to-day medical practice.

We conduct Phases I-IV clinical trials in most therapeutic areas for pharmaceutical and biotechnology companies, maintaining the highest standards of ethics, quality and confidentiality.

Medical Writing

Medical writing plays a critical role in the success of new compounds.

A whole range of regulatory and non-regulatory documents is required during clinical trials. We understand that the success of drug approval is based on the quality of these documents.

We offer expert services ranging from preparing individual documents to producing all the documents needed for the draw up, coordination and documentation of clinical trials in a scientifically correct way. Our teamet challenging timelines, integrate clinical and operational data into concisely written, well structured documents complying with current regulations and guidelines.

Our Medical Writers can assist at any point in the product development lifecycle across Phase I to Phase IV, following ICH guidelines and are compatible with regulatory requirements. Our Writers have extensive professional background, skills in most therapeutic areas and have experience in a wide array of documents of clinical study, regulatory submissions and other documents involving the study to provide expert support at every stage.

We will provide you with the writing skills, relevant medical & scientific background, and experience to produce on time requested medical writing. All of our documents undergo Qality Check review to ensure they are clearly written and meet all the trial requirements.

A team of project managers, biostatisticians and data managers also works together with our medical writers to provide synergy into the clinical trials and effectively communicate your research reports with the regulatory bodies and publications.

Our medical writers can also provide solutions for your publications to add value to your research work.

Our services include:

• Clinical Studies/Investigations
      ◦ Design
      ◦ Protocols
      ◦ Reports
      ◦ IMPDs / INDs / Investigator’s Brochures
• Regulatory
      ◦ Protocols
      ◦ Investigators Brochure
      ◦ Clinical Study Report
      ◦ Patient Documents like Informed Consent Forms
• Commercial
      ◦ Review Articles
      ◦ Manuscripts
      ◦ Case Studies
      ◦ Conference Abstracts

We provide medical writing services as part of the comprehensive clinical trial package or as a stand-alone service.

We understand the importance of good writing. Our goal is to provide you with concise, substantive, and polished clinical documents.

Project management

Ascent CRS offers full-service project management for every stage of your clinical trial. With our highly professional team you can be confident that you trial whether it’s an exploratory design study or late phase trial is in right hands to be conducted timely, correctly and on an agreed budget.

Our team has experienced project leaders on board, who have multiple years of industry experience, and vast clinical and therapeutic practice, especially in complex and critically ill patient populations.

We aim to excel at all stages of study operations:

Feasibility and risk analysis
• Investigation sites recruitment and qualification
Development of project-specific procedures and guidelines
• Pre-study phase and site training
• Investigator and hospital contracts
• Study management and study logistics
Finance and Contract Management
• CRA training and coaching
Quality control management
Safety surveillance and pharmacovigilance

Our project managers:

✓ Ensure GCP adherence
✓ Provide you and study vendors a single point of contact
✓ Put risk and contingency plans in place which anticipates and prevents problems
✓ Manage budgets to minimize change orders
Keep you as informed as you need to be through frequent communications
Escalate important issues quickly and offer solutions
Take ownership of your project and all its deliverables

Our project leaders are the study managers and partner and key point of contact with the sponsor. They create the best suited team for each clinical program and remain responsible throughout the whole trial and supervise the study schedule up to the production of the final report.

As the primary point person, project managers is responsible for overseeing all interactions, managing study sites, coordinating investigator payments, monitoring study metrics, training, assuring adherence to timelines, and coordinating interactions among operations teams.

Our Project Management Approach is based on an ongoing anticipation and management of issues, and offering proactive solutions. Through meticulous planning and co-ordination, our project management model aims to deliver projects with clear focus on providing quality backed by on time and on-cost deliverables.

Our experienced and highly-qualified project managers ensure that your study timelines are met. For the duration of your project, we are focused on consistent quality control to achieve the highest quality data possible.

All our project managers go through extensive therapeutic training, including standard operating procedures (SOPs), Good Clinical Practice guildelines (ICH-GCP) and study specific training on an ongoing basis and at the beginning of each study. Internal audits are also done in conjunction with the project manager to ensure that training is completed.

We believe, that strong project management and close contact with the sponsor are important keys for successfully conducting clinical trials.

Risk-based Monitoring

We have highly proficient monitoring staff each member is fully trained according to internal SOPs and ICH-GCP guidelines and is experienced in conducting site evaluation visits, site initiation visits, periodic monitoring visits, and study termination visits as well as all in-house monitoring functions, including adverse events reporting, and clinical trial material management.

Our clinical monitoring team has experience in monitoring; everything from straight forward outpatient studies to large complex in patient studies.

Our CRA team will assist you with the following clinical monitoring activities:

• Identification and selection of investigators
• Identification and management of IEC / IRB
Regulatory document review and collection
Review of study documents, source data verification, Case Report Forms and Informed Consent Forms
Site contract, budget negotiation, and grant administration
• On-site training
Site qualification, initiation, and close-out
Interim site monitoring
• Handling protocol deviations
Drug accountability
• Second clinical review
• Data query resolution

Our full-service clinical monitoring is conducted in accordance with a well-designed monitoring plan, ICH-GCP Guidelines, applicable regulatory requirements, and our accredited SOPs.

Our on-site study monitoring services include:

Qualification visits (see Study Start-up)
Initiation visits
• Study monitoring visits
Close-out visits

The clinical monitoring team always meets the highest standards and requirements of our clients due to the seamless interaction between the team members and their proactive thinking and fast, accurate execution.

We use a flexible staffing model and have developed our own base of certified and trained freelance monitors located all over Russia and Georgia. Our CRAs monitor only a few protocols at any given time, allowing them to be an expert in all aspects of their studies. With an average retention rate of over 90%, our CRAs are able to see their studies through from start-up to close-out.

Data Management & Biostatistics

We recognize that data integrity is the key to success of any clinical study, whether your trial is a large international study or a single center proof-of-concept trial.

Consistent and high-quality data are our top priority for clinical data management. Our dedicated Clinical Data Management team will help you generate data that meet most demanding requirements.

Our team is able to handle large quantities of data efficiently and support data expertise in every phase of drug development such as collection, organisation, validation, analysis, and the quality control of clinical trial data.

Working together with our partners we provide a seamless flow of data and constant communication to meet all project deadlines and milestones. Our data management experts understand and comply with Good Clinical Data Management Practice (GCDMP) and Clinical Data Interchange Standards Consortium (CDISC) standards.

We ensure production of results that are: accurate, accessible, reproducible, source-verified, timely and cost-efficient.

Our team has experience managing multiple EDC systems, including but not limited to:

• Oracle Clinical RDC
• Merge eClinical OS
• MedNet iMedNet
• Various other EDC systems

As an extension of our clients and a partner in the development of a strategy, we can provide a system recommendation based on the size, scope, and complexity of a clinical trial. Once a system is selected, we work to ensure that system is customized to each client and clinical trial/program.

Our clinical Data Management services include:

• Data Management Trial Master File Set-Up and Maintenance
• Design & Development of Case Report Form/ e-CRFs
• Establishment of the Data Management Plan (DMP)
• Establishment of the Data Validation Plan (DVP)
• Database Design, Development and User Acceptance Testing
• Data Validation Checks Specification, Programming and Testing
• CRFs Tracking
• Double data entry
• Discrepancy Management
• Medical Coding
• Lab Data Management
• SAE Reconciliation
• Quality Audit
• Database lock
• Export of entered and analyzed data

The experienced, well-trained Biostatistical Department at Ascent CRS provides statistical analysis and programming adhering to both clients’ project requirements and ICH E9 guideline for successful trial evaluation.

Biostatistic is pivotal for the success of any clinical trial. We understand its importance at every stage of the clinical trial and we employ Quality Control (QC) practices at all stages of the ongoing project. All our statistical services are based on ICH guidelines.

Our knowledgeable team is dedicated to delivering quality services across a wide range of therapeutic areas and all phases of clinical research by emphasizing on process optimization that shortens time span while ensuring quality.

Our team of experienced biostatisticians has extensive knowledge of study design, statistical methodology, and global regulatory requirements.

Our BioStatistic services include:

• Statistical Analysis Plans
• Protocol, Case Report Form, and Clinical Study Report review
• Power and Sample Size Calculations
• Study Design & Endpoint Development
• Randomization Schedule Preparation
• Statistical Analysis Plan Development
• Planning and implementing Interim Analyses
• Data Monitoring Committee Planning and Reporting
• Integrated Summaries of Safety & Efficacy (ISS/ISE)
• Statistical Consulting

Recruitment

We have developed an efficient strategy, which ensures fast recruitment rates for various patient populations, including treatment naive patients. Based on specific inclusion and exclusion criteria, we aim to provide our partners with realistic and reliable estimations on recruitment rates within the study feasibility process.

Success of our recruitment is guaranteed by a very close collaboration and personal connections to a well defined and tested network of referring physicians within large hospitals all over Russia and Georgia, including centres where our clinical pharmacology units are based. A

We have developed and maintain a large network of referring physicians across most therapeutic areas:

▪ Oncology
▪ Cardiovascular Disease (hypertension, CAD, MI, CHF, acute coronary syndrome etc)
▪ Respiratory Disorders (asthma, COPD , TB, cystic fibrosis etc)
▪ Hepatology
▪ Nephrology
▪ Endocrinology & Metabolic disorders (T2DM, obesity, dislipidaemia, etc.)
▪ Gastro-Intestinal Disorders
▪ Disorders of Immune System and Rheumatology (rheumatoid arthritis, osteoarthritis, psoriasis, lupus etc)
▪ Hematology
▪ Neurology and Mental Disorders (Pain, Parkinson, Depression, Schizophrenia, Multiple Sclerosis etc)
▪ Gynecology
▪ Hepatitis C

Here're our recent recruitment rates:

Recruitment

Deep collaboration with key Hospitals and Universities across Russia and Georgia results in unique access to vast and diverse patient populations including rare diseases. This enables rapid recruitment of required subjects making meeting strict deadlines a reality. 

We also maintain a large database of healthy volunteers who can be included in any trial in Russia & Georgia.

Patient requirements are always different and so are our recruitment strategies, that we always customize and develop for every trial individually.

We know what type of ads and media to use to generate best patient responses in each individual country and therapeutic area. Our proven recruitment process has shown high response rates and timely recruitment progress using phone, e-mail or web based communication tools.

Our recruitment strategies ensure that every study is performed within the timelines as initially estimated and agreed with the Sponsor or even faster.

Our reputation is built on the fact that we almost always stick to the initial recruitment estimation timeframe.

Recruitment services can be contracted as a stand-alone service or as part of a full service project.