Clinical Operations

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Our operations team have broad and deep insights in the local ethics and regulatory framework. They also have strong relationships with investigators and their teams. We are scientists with a passion for operationalising clinical research and we have built a robust reputation of delivering faster, better and to a higher standard.

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Accurate Study Feasibility and Valuable Intelligence of the Local Research Environment

At Axcellant we believe that study feasibility is an ongoing activity. We listen carefully to our investigators and their peers to collect ongoing insights and share these with study sponsors on an ongoing basis. This allows for well-informed decision making throughout the programme.

Rapid Study Set-up through to Site Initiation

We are very proud of our broad diversity within our network. The solid reputation of our organisation locally enables our start-up team to accelerate the set-up of studies at an impressive pace.

Value-based approach to data monitoring and analysis

Our biostatistics and data management team are integrated within our clinical operations team. Together, we review data and ensure that you get the best value on every point of data collected.

People

Processses

Systems & Technology

Study/Programme Feasibility

We take a clinical development plan at any stage of maturity and provide valuable insights so that important decisions can be made quickly. Our clinical operations team build trust in every interaction so that we can exceed expectations.

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1

Research question familiarisation

2

Broad intelligence gathering: experts, analysts and databases

3

Comprehensive analysis and forecasting of: Scientific and Clinical Feasibility Patient recruitment Timelines Budget Probability of success

Study Start-up

Our dedicated study start-up specialists have developed leading processes and systems to
accelerate the start-up of studies. Our strong relationships with investigators and their
teams globally allows us to progress studies with speed and agility.

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Patient Recruitment

Contrary to popular belief, patient recruitment can be projected accurately. At Axcellant we use deep insights in the therapeutic area, local epidemiology data, clarity on the target patient population, the treatment landscape, precedence and local site intelligence to accurately project patient recruitment.

Our team have successfully accelerated patient recruitment in extremely niche patient populations, enabling the timely generation of clinical evidence.

We think outside the box to make this happen and work with a broad range of specialists: All solutions below conform to local laws and regulations.

Creative Solutions

Study Branding and Website Development

Animation of Patient Information

Study Advertisement and Social Media Outreach

Patient Outreach

Engagement with patient advocacy groups

Affiliation with patient support charities

Sponsorship of Patient Targeted Education Material

Investigator Support

Provide resourcing solutions to investigators where required

Establish Centres of Excellence & Hub-and-Spoke Models

Create a robust investigator community (global/local)

Technology

Interface with local multi-disciplinary team meetings

Leverage databases for patient identification

Supporting sites in harnessing the power of EHR

Clinical Monitoring

We can’t eliminate risk but we can identify, characterise and proactively manage it. Axcellant have successfully conducted numerous studies with a truly risk-based monitoring strategy. We work closely with you to categorise all aspects of the study programme to three levels of risk.

From study design to sections of the protocol, site selection through to datapoint level – we have it covered. We understand that risk is dynamic and our systems and processes allows for complete visibility of the dynamic nature of risk and also for re-categorisation should it be required.

Risk-Based Study Management

1. Diligent Risk (Re)Categorisation

2. Central Analysis and Reporting

3. On-site monitoring

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Project Management

Our project management team at Axcellant have “T-shaped” skills in clinical research. They have the depth and breadth of expertise in cross-functional partnerships. Their ability to problem-solve combined with adept soft-skills ensure our customers consistently receive the highest level of service.

Investigator and Team Training

We work cross-functionally with our events management and creative partners to provide our customers with the best training experience. From investigators meeting to GCP training we make the ordinary engaging and memorable. Our training team expertly execute a broad remit from SOP training, to GDPR and study motivational meetings with external experts to Oxford-style debates, we simply do it better.

Services

Newsroom

Key Considerations for Initiating a Clinical Trial: A Comprehensive Guide

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Completion of a significant clinical study

Our team at Axcellant is proud to announce the completion of a significant Post-Market Clinical Follow-up study. This study was…

Unveiling Real-World Evidence in Clinical Trials

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