When you absolutely have to recruit patients on time.

Home 5 Strategic guidance and trial set-up

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.
Regulatory Affairs
  • 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

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.

Investigator Meetings
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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.

We offer:

  • 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
  • Logistics
  • 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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From clinical research associates to hands-on founders, we fiercely pursue our strategic goal: deliver on schedule. We think of ourselves as your development partner, not a vendor.


MAKE EXTENDED GEOGRAPHY YOUR ADVANTAGE


• The US has 1 clinical trial for every 3,000 people.
• Russia has 1 clinical trial for every 38,000 people.
• E.Europe has 1 clinical trial for every 13,000 people.

List of all registered studies is available at ClinicalTrials.gov


CLIENTS SUCCESS STORIES


Outperforming in an Onco-Hematology Clinical Trial

Meticulously selected by Accell, Russian sites twice outperformed enrollment in Western European sites and 6 times in US sites. Read more

Inventive operational strategy for a cardiology rescue study

Phase III clinical trial in cardiology for a global top-10 pharmaceutical company. Accell recruited 130% of promised patients before the deadline for patient recruitment. Read more

Oncology Phase III Rescue Study

After 16 months of slow recruitment, Sponsor addressed Accell to add an emergency country to rescue the study. Accell recruited 21.6% of total patients in just 6 months. Read more

Top Recruiters in Ulcerative Colitis Phase III Study

Accell recruited 84% of total patients, with only 65% of a total number of study sites, and made sure the Sponsor ended recruitment earlier than planned and faster entered the market. Read more

This Is Your Team. We Make Clinical Trials Happen.