Getting a new drug or medical device to market is a challenging process, potential risks need to be limited and costs addressed thoroughly. LINK Medical offers life science companies a strategic partnership that will help them reach the desired market more quickly and with the most optimal use of resources.
As a full-service contract research organisation (CRO), LINK Medical offers more than just the traditional product development services for life science companies. Its in-house team of experts offer services that span from early development through to clinical development and market access.
“We primarily work with clinical development but in addition, we have a rather large regulatory team, a highly-skilled medical device team, a growing market access team and a pharmacovigilance team operational in both pre- and post-marketing services,” says CEO Ola Gudmundsen.
The LINK Medical teams work with clients in all the phases required to bring a new product to the market.
“It’s important to have a solid understanding of the market being entered and what characterizes this market, so we build a Target Product Profile at the earliest stage possible,” Gudmundsen says.
A Target Product Profile (TPP) document outlines the strategy of product development, planning of clinical trials, liaisons with health authorities, and compliance with regulations.
“The pharma industry needs to prepare a business model that ensures that they reach the goals set out to reach. A lot of excellent ideas never materialise because you have not prepared properly or you keep running into errors that could have been prevented with proper planning,” Gudmundsen says.
Bringing a medical device to market, for example, requires that health economic models be prepared in order to compare the product to standard treatments and devices already on the market. Obtaining reimbursements for a new drug can be a time-consuming process and will depend on various terms and regulations, while the reimbursement application must adhere to all requirements and submission deadlines.
“It’s also important that life science companies target the right group of patients and get the right product into the right market. This requires a wide range of resources,” says Gudmundsen. In particular, the field of oncology is a minefield; more than 2,000 products are currently under active development. “Only a small fraction of those products will reach the market, and those who put the most thought into this and have a clear strategy will come the furthest. It’s not just a question of biology, the strategy is equally important,” says Gudmundsen.
LINK Medical’s expert oncology team includes medical specialists with substantial know-how of product development in oncology and related areas such as inflammation and immunology. “We have an excellent team working with strategic oncology trials,” says Gudmundsen.
Life science companies, from small biotech to large established pharma and medical device manufacturers, use the market ac-cess expertise offered by LINK Medical.
“We view ourselves as a strategic partner more than a service provider, in that way we can establish a strong collaboration. We cooperate, talk together and work things out jointly – and in our experience, this makes a huge difference,” says Ola Gudmundsen.
About LINK Medical
• LINK Medical is a full service CRO for biotech, pharma, and MedTech in Northern Europe
• Has 175 employees, servicing customers from offices in Oslo, Stockholm, Malmö, Uppsala, Copenhagen, Berlin and London
• Provides services within all aspects of life cycle management from preclinical to post-market
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