OVERVIEW

Clinical trials and post marketing surveillance studies are essential for regulatory approval and market uptake of products.

 We offer flexible cost conscious, scalable solutions to meet your clinical
development needs.

 We are specialists in developing clinical testing strategies in partnership with our clients helping them reach their milestones for investment, regulatory approval and market access.

 Our team combines extensive knowledge and know-how to design and manage an affordable clinical trial to meet your product development goals.

OUR SERVICES

Our experienced team is internationally networked and on hand to offer expert advice and support in all areas.

CLINICAL STRATEGY DEVELOPMENT

Clinical Strategy Development

At this critical first step, we provide professional guidance to
help you determine the right clinical development plan
to suit your regulatory and commercial goals.

CLINICAL TRIAL PLANNING & MANAGEMENT

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Let us plan and execute the right trial for your
product in partnership with you.
 

POST-MARKET CLINICAL FOLLOW-UP

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Collection of data on real-life clinical experience with your device, once it
is on the market, is an important part of an ongoing regulatory
compliance requirement. We work closely with you to
determine PMCF clinical study strategies.

CLINICAL EVALUATION REPORTS

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Our Clinical Evaluation involves an assessment and
analysis of clinical data relevant to your
medical device and is a critical
component of CE Marking.

We are experienced in adult, paediatric and neonatal clinical research and have worked in primary and secondary healthcare settings.

OUR CLIENTS

Delivering informed, evidence based clinical research

“Our approach is different. Each of our staff has extensive experience in the management and execution of clinical trials and believe that through a better,
innovative approach with a transparent costing and pricing model for healthcare research studies we can do better, together.”
– Nicola Wall, PhD. Chief Executive Officer.

Biopharmaceutical Companies

Clinical trials are at the centre of the development process for new drugs and improved therapies. Designing and managing these trials effectively from the outset is critical to the success of potential breakthrough products. This requires knowledge and expertise complemented by exceptional project management capability. We are particularly keen to facilitate research into orphan indications which are often overlooked and require specialist project oversight.

Wearable Technology Companies

Medical software, wearable technology and mobile technology all have the potential to revolutionise how we effectively manage health and wellness. This growing market has incredible potential to improve quality of life for everyone. There is an important opportunity for companies to provide evidence on the usability and benefits of these products through clinical trials. While some of this technology may not legally require clinical testing, we believe that there are significant advantages to providing evidence of benefit through the clinical trial process.

Medical Device Companies

Companies constantly strive to innovate and improve the delivery of healthcare through medical device advances. The last decade has led to the development of state-of-the-art medical devices and advancement in the healthcare industry.  Changing EU regulations have significantly impacted clinical trials for device companies. Supporting this process with appropriate clinical trial design and implementation is a core part of our offering.

Foundations & Patient Groups

Many charities and not-for-profit organisations fund, drive and facilitate clinical research into new and improved treatments and therapies. They form a critical part of the research infrastructure and are often involved in priority setting partnerships with patients, carers and families. They are able to provide patient and public involvement in research design to ensure that clinical trials are likely to recruit and retain participants. We are committed to providing these groups with a research partnership driven by integrity where commercial considerations are not the driving force.

CRO Partnerships

We have a presence in Ireland and the UK for existing clinical research organisations (CROs) currently without representation in this region. We will work with you to facilitate the full feasibility and successful execution of a trial, using our existing site relationships and knowledge of the local regulatory system. We can also link up with other clinical research service providers in other countries to offer you the widest possible scope.

Industry Organisations

There are a range of organisations that exist to support many of our clients in the clinical development journey. We provide training and ad hoc advisory services in partnership with these organisations in support of our mission to improve the overall landscape for clinical trials.

Investment Community

We understand that many of our smaller clients are funded by a range of individuals and organisations. The value of this investment is directly linked to the success of their client’s clinical development strategy. This is because the clinical development strategy will inform the right development and clinical trial pathway for that product. We work with investors to provide this service to their clients and mitigate risk in the long term.

Technology Transfer Offices

In addition to the investment community, our third level institutions also work with newly emerging spin out companies that require support in terms of clinical development strategies. Many of these very early stage companies require help in the determination of the right clinical development plan for their product created in partnership with experts. This means that their product is given a thorough review in terms of its potential/risks. This is the best start that any new company could wish for in the healthcare space.

OUR TEAM

Designing and managing  clinical  trials is  critical to  the  success of any product. This requires knowledge and expertise complemented by exceptional project management capability. The Afortiori Development Team has over 100 years of healthcare, clinical trial design and management experience.

Meet The Team
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Chief Executive Officer

Nicola Wall

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Chief Operating Officer

Elizabeth Ralph

deirdre
Interim Chief Business Development Officer

Deirdre Foley Woods

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Head of Marketing

Sunjiv Sharma

UPCOMING EVENTS

MED-TECH INNOVATION EXPO

Med-Tech Innovation Expo is the UK and Ireland’s leading showcase for medical design and manufacturing technology and innovation. If you are planning to attend, get in touch as it would give us the opportunity to talk with you about how Afortiori Developments full service offering can benefit your organisation.

DATE:  25th – 26th April 2018
VENUE:  Ricoh Arena in Coventry

PREVIOUS EVENTS

BUILDING A FOUNDATION FOR SUCCESSFUL MEDICAL PRODUCT DEVELOPMENT

Join Afortiori as a unique panel of industry experts present the key issues for consideration around intellectual property, new regulations and reimbursement planning for every business on their product development pathway.

DATE:  Monday 23rd October 2017
VENUE:  PorterShed, Eyre Square, Galway City, H91 HY51

SPEAKERS

Brenda Dooley

Managing Director
Axis Healthcare Consulting

Frank Enright

Consultant
Incra Med

CONTACT US

Phone:

UK Office:     +44 (0) 7597 689276
Irish Office: +353 (85) 117 5029

E-mail:

Enquiries: