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Early Clinical Development

Getting it right. The first time


We know that the right development strategy for your product is critical from the very beginning to ensure an efficient pathway towards the market. Therefore, we provide a strategic partnership where we assess and understand your risks, offering planning and advice to cut time, costs and wasted resources in product development. From designing your Target Product Profile to submitting clinical trial applications, we offer full and flexible service solutions, and our specialist team will actively communicate with you to customize the services according to your company’s specific needs. LINK Medical services will empower your decision-making throughout the process and lay the groundwork for a smooth product development.

Target Product Profile (TPP) consultancy and workshops

We help you outline the strategy for your product to enter the market by highlighting the clinical development and regulatory plans required, as well as performing production and Chemistry, Manufacturing and Controls (CMC) planning. Our one-day TPP workshops have been a resounding success with clients as a quick and to-the-point support that helps propel their further product development.

Regulatory support
With one of the largest regulatory teams in Northern Europe, we can help you clear every regulatory challenge with confidence. We offer a variety of early development services and support including regulatory planning, gap analysis to ease clinical trial application submission, scientific advice, CMC, preparation of the IMPD, and compilation of the Regulatory Package. Read more about our full regulatory services.
Scientific Advice
Scientific advice helps to ensure that our sponsors perform the appropriate tests and studies, so that no major objections regarding the design of a clinical study are likely to be raised during the evaluation of the Clinical Trial Application and later the Marketing Authorisation Application. This also helps avoid patients taking part in studies that will not produce useful evidence.

Our team has extensive experience advising our clients about the most appropriate way to generate robust evidence on a medicine’s benefits and risks. For a medicine to be authorised, medicine developers have to demonstrate that it is effective, safe and of good quality.

Quality Assurance support
The importance of early quality management is crucial to successful product development. We will build and maintain your Quality Management System (QMS), and support your company in audits (vendor, QMS, and systems). Read more about our full quality assurance services.
Medical Support
Our medical officers will fully support you throughout the planning phase of your clinical trial. These officers are also on-hand at our TPP workshops, offering specialist medical expertise that helps inform and accelerate your product development.
Project Management
Our project management services can include providing you with a hand-picked expert who will drive all pre-clinical activities to agreed timelines and foster proactive team management, as well as coordinate the compilation of documentation necessary for the clinical trial. Read more about our full project management services.
Medical Writing
Our team of medical writing experts can support the production of key early development documents, and can also summarize the CMC and non-clinical pharmacology and toxicology data. Read more about our full medical writing services.
Business plan
We can support your market and financial planning, including reimbursement planning. We also offer advice on due diligence processes and on how to attract investors.

Business area head:

Marie Moores
Executive Vice President Early Development

Marie joins LINK Medical with a background in senior management and board membership within the CRO industry for over two decades. She holds a degree in Clinical Research and has longstanding experience in clinical development and regulatory strategy within the field of oncology, advanced therapies, biologics and gene therapies. She also serves the European Commission in reviewing the progress of Horizon 2020-funded clinical trials as an external expert and monitor.

marie.moores@linkmedical.eu

“The TPP workshop gave us an excellent, clear understanding of the regulatory pathway. Having experts from different areas of the health care sector in the same room, answering all our questions, was a fantastic benefit for us”

Mohamad Takwa, CEO Thyrolytics

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