Improved clinical outcomes to deliver new drugs for Patients faster.
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. 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 strong full-service regulatory team with highly experienced experts that provide guidance and regulatory advice for pharmaceutical as well as medical device products. We also have a growing Market Access team and a Pharmacovigilance team operational in both pre-market and post-market services. Last year, despite of the pandemic, our German team grew steadily, creating very effective teams for management of clinical trials, and strengthening our experienced medical device team. We offer our customers a gateway into Europe in one of the largest medical device and pharma markets.” says CEO Ola Gudmundsen.
The LINK Medical teams work with clients in all the phases required to bring a new product to market.
“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 a substantial knowhow 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 access 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 create value for our customers when we take the whole picture into consideration including regulatory guidance, study conduct and market access.
Our refined way of working has proven to be very effective. We were very happy to see in our latest customer service survey that 97% of our customers would recommend working with us. Moreover, quality, service mindedness and proactive communication were ranked as the three most important aspects when choosing a CRO partner. We cooperate, talk together and work things out jointly – in our experience, this makes a huge difference,” says Ola Gudmundsen.