When you absolutely have to recruit patients on time.
We improve clinical study performance, whether you need a strategy for execution of your clinical trial, a defined vision for study rescue, or need expert consultation on study development, Accell has the expertise to assist you
Strategic planning and identification of the right regions and clinical investigators is a major success in the execution of the clinical trials. There is no cookie-cutter recipe for identification of the locations and sites, as each study is unique – our goal is to make each a success.
STRATEGIC GUIDANCE AND TRIAL SET-UP
Study Feasibility, Site Selection and Strategy
- Initial assessment of optimal country and site selection based on the competitive landscape, protocol feasibility, regulatory requirements;
- Consultation on specific indication and ethical aspects of the trial by our in-house physicians;
- Defining patient recruitment and retention strategy and identifying risk factors;
- Access to a broad network of sites and investigators across the region. Our established oncology network across the region amounts to over 150 sites and cardiology network covers over 200 sites, just to name a few.
Study Documentation Development
- Statistical consulting and statistical analysis plan;
- Protocol, Investigator’s Brochure, ICF, Patient Diaries, Case Report Forms (CRF/eCRF), Literature Reviews;
- Certified translations of clinical study documents into local languages.
- Clinical Trial Application preparation and filing with the Regulatory Authorities and Central Ethics Committees;
- Ongoing communication with regulatory authorities throughout the study and ensuring strict adherence to regulatory requirements.
Clinical Supply Import and Management
- Procurement and management of import and export licenses;
- Preparation and implementation of clinical supply plan;
- Identifying, contracting and oversight of logistical chain vendors;
- Oversight of import and export procedures for study drug and biological samples.
Advisory Boards can be established to provide companies with essential insights into topics covering many aspects of clinical R&D from regulatory submission, to clinical trial protocols, to clinical trial design and patient safety. Within the frame of a clinical trial, some advisory board members may also serve as Key Opinion Leaders on the trial.
At Accell, we work with renowned physicians across many therapeutic areas and offer our knowledge and academic resources to our clients. The approach to each client is individual as the needs for an advisory board are unique in each situation, but one factor remains constant: our commitment to facilitating access to the most relevant academic and clinical experts for our clients’ scientific needs.
Study Budget and Contract Negotiation
Study budgets and site contracts are often one of the key risk factors affecting start-up timelines. Accell realized the critical importance of this process and facilitates site contracting. In a multinational environment often language and time difference becomes an important influencing factor of success.
- Local legal entities for convenience of contracting;
- Administration of payments in local currencies across the region;
- Local staff for contract negotiation in a local language, however, centralized overall management and approvals of the entire contracting process for consistency and transparency;
- Management of site and investigator grants.
Selection and Management of Clinical Study Vendors
We can recommend and work with various vendors required in various study settings. Accell has established relationships and pre-qualified vendors in the following areas:
- Central laboratory (biomarkers, gene expression, PK/PD, etc)
- Customs brokers
- Drug sourcing and warehousing
- Central ECG and imaging
Our clients can take advantage of Accell managing the pre-qualified vendors with a clear and transparent team structure and reporting approach.
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MAKE EXTENDED GEOGRAPHY YOUR ADVANTAGE
• Russia has 1 clinical trial for every 38,000 people.
List of all registered studies is available at ClinicalTrials.gov
CLIENTS SUCCESS STORIES
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