When you absolutely have to recruit patients on time

Home 5 Clinical Trial Management

We give hope to the patients, and we relentlessly pursue our goal of meeting the clinical study targets by individually crafting and implementing sharp operational strategies.

clinical trial management

Project Management
Good management practices are the cornerstone of successful and efficient clinical trials. We employ experienced project managers and clinical staff, who are able to identify risks and plan contingencies, efficiently manage resources and timelines, know their sites and investigators and are excellent communicators.
Clinical Monitoring
We operate via local CRAs in each of the countries to ensure that our clients have immediate access to local knowledge, under robust, centralized SOPs. Source documentation is monitored in a local language, while the CRFs are most typically in English for multinational, multicenter clinical studies. In addition to English language proficiency, most CRAs have a Medical Doctor degree, taking the work with investigational sites to higher levels of professionalism. Monitoring of the clinical site is one of the critical success factors of a clinical study; it ensures an accuracy of records and quality of data and provides the investigators with the support they need throughout the clinical study. The relationship between the CRA and the investigator can easily influence the clinical study conduct. We believe that building trust and respect between investigators and CRAs goes a long way in achieving a successful clinical study operation.
Data Management and Biostatistics

Our services are built for regulatory compliance:

  • eCRF cloud-based SaaS tools;
  • CDASH conformance;
  • 21 CFR Part 11 compliance, full validation;
  • IxRS, ePRO;
  • SAS and R for statistical programming.
Clinical Trial Safety Management
  • Safety management database design, validation, and maintenance;
  • Coding of adverse events;
  • Reporting of Serious Adverse Events (SAE) and SUSARS to the Sponsor and appropriate follow up with the site;
  • Expedited reporting of SAE/SUSAR to Regulatory Authorities and Local EC/IRB per local regulations.
Medical Monitoring

The safety of patients is paramount in clinical research, and ensuring compliance with the study protocol or procedures is crucial for the study to meet its stated objectives. Our Medical Monitors are Medical Doctors (MD) that can provide medical oversight of clinical studies across the regions and a wide range of therapeutic areas. We offer medical and strategic consulting and safety review services for clinical trials as follows:

  • Medical review and input into study protocols and key clinical study documents;
  • Addressing patient eligibility and ongoing medical issues in the protocol;
  • Reviewing of all Adverse Events;
  • Designing the clinical programs from the selection of indication to protocol design, through key clinical trial documents;
  • Recommending, establishing and working with Advisory Boards.
Quality Assurance
  • Internal QA/QC team;
  • Verification of study compliance to ICH E6 (GCP), applicable laws, study protocols, policies and Standard Operating Procedures (SOPs);
  • Audit of investigational sites and clinical trial vendors.
TMF/eTMF Services

Accuracy and completeness of clinical trial records are essential for evaluating compliance of the clinical trial with GCP and the integrity of data. We manage the Trial Master File in the course of a clinical trial to ensure that trial documents are accessible by the appropriate individuals and available for regulatory inspections, and allow the Sponsor to effectively manage the trial. Our services include:

  • Paper or electronic TMF (e-TMF) management;
  • E-TMF platform that has been validated and compliant with 21 CFR Part 11.

Our Services

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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.

Functional Outsourcing

Rescue Studies

Clinical Trial Management

Strategic guidance and trial set-up

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MAKE EXTENDED GEOGRAPHY YOUR ADVANTAGE

 

Accell's global clinical trials capabilities

▼Roll the cursor over each country to see the number of registered clinical trials. List of all registered studies is available at ClinicalTrials.gov.▼

 

 

• 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.

 

 

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.

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