Clinical Operations

Excelya>Capabilities>Clinical Operations

Smooth Execution for a Simplified Journey

As you go through the clinical development process, unforeseen risks and hurdles can cost you significant time and money. Excelya offers all necessary clinical operations & project management capabilities to ensure smooth execution of clinical trials, from phase I to IV, to simplify your journey to market. We offer regulatory expertise, medical writing and communications and data operations to see you through to the post-market phase.

Our Services

  • Study and country feasibility
  • Site Identification and Selection
  • Site Contract Management
  • Regulatory Submission of the Clinical Trial Application
  • Leading/Local Ethics Committee/IRB submission
  • Patient Recruitment
  • Monitoring: from Site Initiation to Site Closure
  • Remote Monitoring activities
  • Risk Based Monitoring
  • International Monitoring
  • Pharmacovigilance and Safety Handling
  • Vendor Management

The Excelya Difference

  • Medical review/advisory on study aspects and conduct
  • European coverage with 17 country offices and 800 experts
  • Organizational structure aimed at long term retention and development of our employees, in order to ensure high-quality service delivery and stable project teams
  • Attractive size that enables us to perform on large scale projects, while at the same time leaves enough room for flexibility to meet specific client needs
Safety, accuracy, integrity

Expert staff, inside and outside

Our Clinical Operations team works closely with local and international Key Opinion Leaders and with our pivotal operational departments, such as Medical Writing, Vendor Management, Regulatory Affairs, Data Management and Pharmacovigilance to quickly deliver trials that meet the highest standards. Our highly flexible and customer-centric approach ensures constant communication with our clients to make sure your trial is done right.

Vendor Management

Vendors aligned to your objectives

Our comprehensive central services solution aligns all of your vendors to work together towards your objective. Our Contributors find simplicity within complexity.

We leverage a functional and organizational “Deliverables” model implemented in Trial Operations called Vendor Management and Oversight (VMO). This model deploys dedicated specialized Contributors for each centralized activity of the study covered by VMO.

These activities include:

  • Central Laboratory Services (CLS)
  • Bioanalytical & Local Labs
  • IRT
  • COA and eCOA
  • Home health services / Home nursing
  • Central Reading (imaging)
  • Cardiac Safety
  • RespiratoryActigraphy
  • eConsent
Excelya biotech consulting

Features of our VMO contributors

CROSS-DISCIPLINARY: Have cross-disciplinary view across multiple therapeutic areas and are part of the Study team.
SPECIALIZED: Service experts specialized in managing their activities across studies.
FLEXIBLE: Flexible working patterns to cover multiple time zones.
COVERAGE: Are typically involved in several studies.
TASK-ORIENTED: Work based on a specific list of tasks which defines their scope.
EXCELYATES: Are Excelya employees and we will indemnify clients against co-employment risk.

Case Study - Vendor Management, Top 5 Pharma

Decreased costs by 16%

We assessed all vendors and scope of work to harmonize resources and reduce study costs by 16%.

Optimized time by 10%, twice

In the first 18 months, we optimized time spent by 10%.
Another 18 months later, we had optimized by another 10%.