AmeRuss Services

AmeRuss's services encompass all the necessary and beneficial steps to completing a clinical trial cost-efficiently. Trial conduction strictly follows established AmeRuss's Standard Operational Procedures (SOPs) or sponsor's SOPs per sponsor’s preference. Our staffing experience requirements are high: Project Managers, 5 years; Lead Contract Research Associates (CRAs), 3 years; and team CRAs, 1 year.

Phase I and Bioequivalence studies

AmeRuss offers services in phase I and bioequivalence studies in cooperation with specialized phase I providers in Russia and the US that include:

Phase I study protocol and CRF development
Study conduct in healthy subjects and special populations
Regulatory submissions and approvals
Importation and handling of study products and clinical study supply including:
1. Customs clearance
2. Study product and clinical supply depot in Moscow
3. Shipment of study products to study sites
4. Tracking study product distribution
5. Retention and destruction of study products as required
Interim Monitoring Visits
Data Management
Statistical analysis plans
Statistical analysis of pharmacokinetic and pharmacodynamic data
Statistical analysis of safety data
Reporting

Phase II-IV drug and medical device studies

AmeRuss provides the following Clinical Operations Services for:

Feasibility Assessments
Pre study documentation collection, review, and translation
Regulatory submissions and approvals
Study sites selection, qualification, and recruitment including clinical research agreements
Conduction of investigator's meetings and site personnel training
Pre Study Assessment Visits, Interim Monitoring Visits, and Study Termination Visits
Importation and handling of study products and clinical study supply as outlined for Phase I and Bioequivalence studies.
Central / Local Lab Management
Shipment of blood and biological samples including preparation of required documentation and customs clearance
Investigator and institutional grants administration
AE/SAE management and safety reporting

Quality Assurance

AmeRuss Quality Assurance is a systematic and independent examination of study related activities and documents to determine whether the evaluated study related activities were conducted according to the protocol, SOPs, ICH GCP, and the applicable regulatory requirements, and includes Audit Plan, Audit Visits, and Audit Reports.

Project Management

AmeRuss offers Project Management with the depth of knowledge and experience necessary to effectively manage any situation that may arise throughout your clinical trial.

AmeRuss Data Management Services

Database development
Double data entry
Data coding
Query generation and tracking

AmeRuss Biostatistical Services

statistical consulting
statistical sample size calculation
strategic development program planning
statistical and analytical plans
randomization plans
statistical programming
statistical interpretation and reporting
regulatory representation
statistical advice on study design

AmeRuss Medical Writing

AmeRuss offers to prepare the following documents:

Study protocols for clinical phases I to IV
Case Report Forms
Ethics Committees applications
Trial reports according to ICH GCP-guidelines
Prepare drafts for publication and professional presentation

AmeRuss Compassionate Care Initiative

AmeRuss's overarching principle in accomplishing its business goals is first to provide the highest quality care to the subjects/patients in any trial in which we participate. In doing so, we "put the subject/patient first". Our core competency focuses on the goal of managing and executing trials in the most efficient and effective ways possible. However, these goals are subservient to ensuring the best medical interests of subjects/patients. By adhering to this standard, the rest of our goals will be achieved.

AmeRuss pursues an active interest in assisting and facilitating Compassionate Care programs at every opportunity. Our in-house expertise and experience can help sponsors and other organizations to realize these social imperatives. Consider AmeRuss to assist your firm in these objectives throughout our region.


		AmeRuss Services AmeRuss's services encompass all the necessary and beneficial steps to completing a clinical trial cost-efficiently. Trial conduction strictly follows established AmeRuss's Standard Operational Procedures (SOPs) or sponsor's SOPs per sponsor’s preference. Our staffing experience requirements are high: Project Managers, 5 years; Lead Contract Research Associates (CRAs), 3 years; and team CRAs, 1 year. Phase I and Bioequivalence studies AmeRuss offers services in phase I and bioequivalence studies in cooperation with specialized phase I providers in Russia and the US that include: Phase I study protocol and CRF development Study conduct in healthy subjects and special populations Regulatory submissions and approvals Importation and handling of study products and clinical study supply including: Customs clearance Study product and clinical supply depot in Moscow Shipment of study products to study sites Tracking study product distribution Retention and destruction of study products as required Interim Monitoring Visits Data Management Statistical analysis plans Statistical analysis of pharmacokinetic and pharmacodynamic data Statistical analysis of safety data Reporting Phase II-IV drug and medical device studies AmeRuss provides the following Clinical Operations Services for: Feasibility Assessments Pre study documentation collection, review, and translation Regulatory submissions and approvals Study sites selection, qualification, and recruitment including clinical research agreements Conduction of investigator's meetings and site personnel training Pre Study Assessment Visits, Interim Monitoring Visits, and Study Termination Visits Importation and handling of study products and clinical study supply as outlined for Phase I and Bioequivalence studies. Central / Local Lab Management Shipment of blood and biological samples including preparation of required documentation and customs clearance Investigator and institutional grants administration AE/SAE management and safety reporting Quality Assurance AmeRuss Quality Assurance is a systematic and independent examination of study related activities and documents to determine whether the evaluated study related activities were conducted according to the protocol, SOPs, ICH GCP, and the applicable regulatory requirements, and includes Audit Plan, Audit Visits, and Audit Reports. Project Management AmeRuss offers Project Management with the depth of knowledge and experience necessary to effectively manage any situation that may arise throughout your clinical trial. AmeRuss Data Management Services Database development Double data entry Data coding Query generation and tracking AmeRuss Biostatistical Services statistical consulting statistical sample size calculation strategic development program planning statistical and analytical plans randomization plans statistical programming statistical interpretation and reporting regulatory representation statistical advice on study design AmeRuss Medical Writing AmeRuss offers to prepare the following documents: Study protocols for clinical phases I to IV Case Report Forms Ethics Committees applications Trial reports according to ICH GCP-guidelines Prepare drafts for publication and professional presentation AmeRuss Compassionate Care Initiative AmeRuss's overarching principle in accomplishing its business goals is first to provide the highest quality care to the subjects/patients in any trial in which we participate. In doing so, we "put the subject/patient first". Our core competency focuses on the goal of managing and executing trials in the most efficient and effective ways possible. However, these goals are subservient to ensuring the best medical interests of subjects/patients. By adhering to this standard, the rest of our goals will be achieved. AmeRuss pursues an active interest in assisting and facilitating Compassionate Care programs at every opportunity. Our in-house expertise and experience can help sponsors and other organizations to realize these social imperatives. Consider AmeRuss to assist your firm in these objectives throughout our region.