GHP Healthcare & Pharmaceutical Awards 2018

30 GHP / 2018 Healthcare & Pharmaceutical Awards , Since its inception in 2007, Ladulaas has flourished, and over the past 11 years the firm has undertaken almost 80 trials during this time. As a privately owned independent clinic conducting trials for big international pharma and med-tech companies, prestigious universities, and CROs, from around the world, Ladulaas has achieved a great deal since it first began, and as such it is understandable that Katarina is keen to showcase this success in greater detail for us in her opening comments. “At Ladulaas, we conduct studies on pharmaceuticals, medical devices and nutrient solutions, with the number of participants ranging from just a few up to 150. Our clinic is truly unique. Usually most Clinical Trials in Sweden are run at hospitals and there are very few private actors in this field, but public healthcare today is very strained and as such providers have less time to spend on other tasks. As such, we aim to offer solutions that will support our clients and allow them to surmount this problem.” As part of its quest for excellence, Ladulaas has had four audits from pharmaceutical companies and one inspection from Läkemedelsverket (the Medical Products Agency), all Clinical Trials Experts of the Year 2018 - Nordic Region Ladulaas Clinical Trials offers drug tests as well as studies of medical inventions and food with health effects. As part of our round-up of a selection of our Healthcare & Pharmaceutical Awards for 2018, we caught up with Katarina Berndtsson Blom to learn about the secrets behind the firm’s incredible success. of whom have given the clinic high ratings. This offers clients and participants alike the peace of mind of knowing that they are in safe hands when they work with this dynamic and innovative clinic. As a result, the clinic has been commissioned to undertake a range of trials in various spaces, drawing on the vast experience and expertise of its staff, as Katarina explores further. “Since I personally specialise in Family Medicine, at Ladulaas we are able to conduct trials in a wide range of fields. Around 2008, we for instance, started to test the new diabetes drugs that are now reaching the market worldwide. During a five-year period we had the new antikoagulants, NOAK, on trial that are now replacing Warfarine. “Alongside this, we are currently conducting long term follow-up studies on a vaccine for shingles besides a study for toenail- mycosis, a re-infarction-preventive study in subjects that have already had one or more myocardial infarctions, osteoatrthritis in knees or hips, a nasal vaccine study and a trial in subjects with overweight. In a near future we are starting a psoriasis study and also a trial to test a new substance to treat diabetes mellitus type II.” Over the years, the industry has changed dramatically, and these developments offer Ladulaas many new challenges to overcome. However, as evidenced by her comments on the changing industry, Katarina views these challenges more as opportunities for further enhancement of her clinic’s services and processes. “Since we started the clinic there has been a big change in how clinical trials are performed. In the beginning we had paper CRFs to document the visits for the study-patients. We filled them in during the visit and when the patient left the visit was done. After checked by the study monitor it was sent to a Data Management Department for entering into a computerized system. Now everything is held in electronic records. All ‘feeding’ of the electronic systems that earlier was done by Data Management, is now performed by us after the patient’s gone home. We spend more time with our computers than with the patients. There are also so many different electronic systems in each study. Systems for screening and randomization, systems for E-diaries, ECG, 24 hrs blood-pressure measurements, spirometry, labs and pharmacy and as many usernames and password to keep track on. Over the coming years we aim to improve our system to include an easier means of securing it, for example using fingerprints. HP180026 “Additionally, pharma companies are now outsourcing study related tasks that they earlier had their own staff doing. This means that we have to keep in contact with a lot more people that also change over time since the personnel turnover rate in CRO companies are very high. A consequence of the outsourcing is also that it is hard to get a quick answer when we have questions. Despite this, at Ladulaas our ongoing aim remains to offer clients the very highest possible standards of support and provide safe, effective and compliant clinical trials.” In recent years, the clinic has been awarded a number of international prizes, and Katarina attributes this to the high-quality data that it delivers to the sponsors and to its strong results in recruiting study- participants in time. “To ensure excellence for our clients, we are a very flexible organization and can adapt quickly to what’s required and my personnel is fantastic. It’s the same personnel as from the start of the company. Winning an award is a quality stamp, which makes it easier for us to get new assignments. Our greatest challenge always, is to find the right participants for each study, however, usually we succeed very well with this. We have often been the best recruiting site in both Sweden and globally thanks to our client service and high standards.” With regards to the future of Ladulaas, Katarina has high hopes for even greater success, as she is honoured to conclude. “For the future I hope that it will be less complicated to perform clinical trials in terms of that all electronic systems and devices will become real aid instead of hindrance. I am also keen for feasibilities for new studies to keep rolling in, at an even pace so that we can start a new study every other month. “Ultimately, having achieved 11 years successful operation, it is safe to say that everyone here at Ladulaas is aiming for at least another 11 more. We look forward to supporting our clients and sponsors over the coming years and providing the same quality service that they have come to expect from us.”