ACCELL Clinical Research, LLC.

Accell Clinical Research is your top choice CRO for clinical research services in Russia, Ukraine, Georgia, and Eastern Europe.

ACCELL is a full service contract research organization (CRO), providing high quality custom-tailored clinical trial solutions for our Sponsors. We pride ourselves on excellent customer service and high quality performance with results delivered on time. Key driving force behind our organization is highly motivated professional staff. The primary focus areas are clinical trials for pharmaceuticals, clinical trials for medical devices, clinical trials for functional foods and registration of medical devices.

In addition to our own resources in Russia, Bulgaria, Ukraine, Baltic states, we have carefully selected partners who service our clients in Western Europe, US, and Canada.

Our Clinical HQ office is centrally located in Saint Petersburg with easy access to city center and leading medical institutions, such as State Medical Acedemy n.a. Pavlov and Military Medical Academy. Customer data security is ensured both on our secure corporate network and physically, as the office provides a high level of physical security with electronically-controlled access and video and motion surveilance.

We help to cure people and enhance individuals' quality of life. Our mission is to assist in discovering and bringing to market novel efficacious treatments for various indications as well as products designed for healthy lifestyle by providing clinical trial services to pharmaceutical, biotechnology, medical device and nutrition manufacturer companies.

The name ACCELL combines the words Acceleration and Excellence, reflecting our strategic geographic position in one of the leading patient recruitment areas of the world, which ultimately leads to the reduction of time necessary to complete the trial; and a thoughtful and detail-oriented approach, which accompanies any task, large or small.

We focus on providing excellent customer service and unsurpassed quality of work.

Our corporate philosophy incorporates the attention to professional growth of our employees. We believe that our people are our ultimate driving force, so personal and professional development and satisfaction of staff is an important aspect of our operations. A well-composed team of professionals in the clinical research industry is at the disposal of our valued customers to guide and execute their projects.

We invite you to become our customers and take advantage of Russia's and neighboring countries' fruitful clinical trial landscape, with your trials executed with Acceleration and Excellence.

We provide a full range of clinical trial services in Russia, Ukraine, Eastern Europe, and Georgia.

Feasiblity Analysis
Our involvement starts at the feasibility analysis stage, when we provide expert consultation and thorough research on planning and execution of any given clinical study or registration in Russia and Eastern Europe. Our process involves close collaboration with the Sponsor's team, detailed protocol review and consultation on regulatory affairs, patient recruitment strategy and site selection, import and export requirements and study material logistics, as well as other aspects of clinical trials in Russia or Eastern Europe.

Project Management
Project Management serves as the main liaison with the Sponsor's team and ensures careful planning and execution of the project, adherence to the timelines, risk management and contingency planning, and collaboration with Quality Assurance department to ensure the quality of results.

Clinical Monitoring
By working with ACCELL, our customers benefit from access to local expertise in each country via our staff of experienced CRAs and other clinical trial professionals. Clinical monitoring is performed by specialists with Medical Doctor degrees or PhD level degrees in life sciences.

Regulatory Support
Russia, Ukraine and neighboring countries continue to be increasingly attractive areas for conducting clinical trials in pharmaceuticals and medical devices. The regulatory requirements in these countries can be challenging to navigate, however. We provide consultation and support for obtaining regulatory approval and ethics approval for conducting clinical trials in each country, and maintain communication with regulatory authorities during the clinical study.

Logistics and Storage
Import of investigational products, clinical trial materials and organization of export of samples and equipment can also pose a significant challenge due to the local import and export regulations. We serve as our customers' guide through the process of procurement of import and export licenses, and planning of the logistics process. Our Central Depot located in Saint-Petersburg offers various storage conditions for pharmaceuticals controlled with electronic equipment. The Central Depot is compliant with Good Storage Practice for Pharmaceuticals and SOPs.

Quality Assurance
The role of ACCELL's Quality Assurance department is to advise management on compliance of studies to ICH-GCP and local regulations. We perform inspections of all studies at ACCELL and we offer QA of studies as a stand-alone service to our customers.

Marketing Authorisation
Procurement of Marketing Authorisation for medical devices in Russia will be less complicated, as you can rely on our experience and experience of our partners in the area of importing, procurement of marketing authorisations, and distributing of medical devices and materials in Russia. We have an established interface with the appropriate authorities to enable more efficient communication.

Pharmaceutical products
The number of clinical trials conducted in Russia and Eastern Europe has been steadily increasing, as companies have been realizing the benefits of conducting studies in these countries, such as:

• Rapid patient recruitment
• Highly qualified and experienced investigators
• Well-equipped study centers
• Motivated and compliant patients

ACCELL focuses on conducting Phase II-IV trials in the major therapeutic areas:

• Oncology
• CNS
• Cardiology
• Endocrinology
• Infectious Diseases
• Psychiatry
• Pulmonology

We have established strong professional relationships with medical centers and investigators in these and other indications. Medical centers in Russia have experience conducting industry-sponsored clinical trials in these therapeutic areas.

However, we are not limited by these key areas, as our staff members have diverse medical backgrounds, allowing us to provide expert clinical trial services in many other indications.

ACCELL relies on the expertise and background of its management and core staff. The diverse professional backgrounds include management and conduct of clinical trials in such key therapeutic areas as:

• Oncology ( Breast cancer, non-small cell lung cancer (NSCLC), prostate cancer, T-cell leukemia, colorectal cancer, cervix cancer, gastric cancer, renal cell carcinoma)
• Endocrinology (Diabetes mellitus)
• Pulmonology
• Chronic Obstructive Pulmonary Disease (COPD)
• Cardiology (Myocardial infarction, ischemic disease, arterial hypertension)
• Pediatrics
• Infectious diseases
• Immunology

Medical devices

ACCELL relies on the 10-year expertise of its founding companies with medical device testing and registration for subsequent import and sales on the Russian market. We offer the advantage of established processes for registration of medical devices, and access to our nationwide network of medical centers, which have experience specifically in clinical trials with medical devices.

We put our expertise with medical devices in Russia at our customers' disposal. Our nationwide network of medical centers, which have prior experience in conducting specifically clinical trials for medical devices, supports studies of medical devices in many indications.

We invite our prospective customers to take advantage of our initial courtesy consultation on this topic, to see how we may meet their requirements for clinical trials of medical devices in Russia.

Top reasons to place clinical trials in Russia and Eastern Europe

• Suitable Demographics and Disease Profiles
  With a total population of over 212 million potential study subjects, the region where ACCELL operates offers unsurpassed clinical trials market potential. The patients are of European origin and with similar disease profiles as those in the Western countries, and many are treatment-naïve. Low migration rates and patient compliance offer the benefit of high patient retention rates.
• Exceptional Speed
  Centralized medical centers serve the needs of the patients from large geographic areas, and patients with similar conditions are treated in the same department. Such structure opens up unparalleled access to a diverse patient population and allows companies to recruit up to 10 times faster than in the United States – reducing the time and money necessary to conduct a clinical trial.
  Thus, the region yields an opportunity to reduce time to market and cost of research by significantly reducing the duration of the recruitment phase.
• Highly Competitive Cost
  ACCELL has established networks of medical institutions in Russia and other countries, which allows rapid identification of the most effective patient recruitment solutions for any particular trial. The region’s exceptional recruitment rates reduce the total time necessary to complete the trial and the investigator fees tend to be lower in this region than in the US and Western Europe. Combined, these factors lead to overall highly competitive costs of clinical research.
• High Quality of Data
  ICH-GCP standards have been incorporated into the national legislatures. Requirements for Central and Local Ethics Committee Approval are applicable in all countries in the region. Medical education traditionally has been very powerful across the region, resulting in highly qualified doctors working in the national healthcare system. Strict national clinical trial regulations in Russia ensure participation of only the experienced investigators in the studies.
  ACCELL’s Quality Assurance Department inspects all studies for compliance to ICH-GCP and local regulations.

Business Development HQ

Accell Clinical Research, LLC
3375 Hidden River Parkway, Suite 300
Tampa, Florida 33637

Tel.: +1 (813) 975 - 7236
Fax.: +1 (813) 971 - 0180
Email: bd@accellclinical.com

 

Clinical Headquarters
Accell Clinical Research, LLC
15 Chapaeva Street
Suite 404
Saint Petersburg, Russia 197101

Tel.: +7 (812) 332 - 6387
Fax.: +7 (812) 332 - 6397
Email: info@accellclinical.com / bd@accellclinical.com

Contact Information

ACCELL Clinical Research, LLC.
Leila Bushara, Senior Project Coordinator
15, Chapaeva str., Ste 404
Saint-Petersburg 197101 Russian Federation
Phone: +7 812 332 63 87
Fax: +7 812 332 63 97
E-mail:

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