SUCCESS STORIES
ARE TAILOR-MADE
WELCOME TO SCANDINAVIAN CRO
FULL-SERVICE CLINICAL CONTRACT RESEARCH ORGANISATION, CRO
HOW CAN WE HELP YOU?
Scandinavian CRO is a full service Contract Research Organisation with years of experience in running as well as staffing clinical trials in many different therapeutic areas.
Headquartered in Uppsala, we are at the heart of one of Europe’s biggest Life Science
clusters, and Scandinavia.
ABOUT SCANDINAVIAN CRO
Are you looking for a CRO with a focus on clinical trials within Scandinavia? That’s us.
Scandinavian CRO is a full service Contract Research Organisation offering both consultancy and specific, stand-alone services. If you want to hire a consultant, you can choose
between various specialists, such as project managers, clinical research associates, administrators and research nurses.
It is easy to get lost amongst all the national and international laws and regulations governing clinical trials, so it can be nice to sit back and relax in the knowledge that someone is taking care of Good Clinical Practice (GCP) and all the issues related to it. You will
naturally always be in control and have oversight of your study, but we are happy to do the
work for you, whether you want a consultant or another study specific service.
If you want to use us as an intellectual resource or sounding board, we are happy to share
our expertise with you. We can handle phase I to IV clinical trials in a wide range of therapeutic areas or handle clinical investigation details for medical devices.
OUR
VISION
Scandinavian CRO’s vision is to help our clients
to perform better clinical research.
Better quality, design and speed in every step
of the process.
CLINICAL SERVICES - FROM REGULATORY SERVICES TO MEDICAL WRITING
Time is money, and all clinical trials are unique. Tell us what you would like help with, and
we can discuss your needs together and find a solution that you are happy with. Perhaps
you need help with a submission to the Medical Products Agency, the Ethical Review Board or a Biobank? Or maybe you would like help with monitoring or with statistical analysis. There are many ways in which to solve a problem.
PROJECT SERVICES - EVERYTHING YOUR PROJECT NEEDS
SCRO offers services such as submissions to ethical committees, choice of clinical institution, overall project management and monitoring of all phases of drug and medical
device trials. We can also offer you help with the following services within your project;
Feasibility - evaluating clinics
Regulatory Services - ensure your project follows local and international regulations
Pharmacovigilance - safety monitoring and SOP systems
Medical writing - results are written
Biostatistics - helps you draw statistically valid conclusions
Data Management - tailor-made solutions
GCP training - meet the requirements for GCP training
MedCenter - medical support and call center services in clinical trials
SmartPhone Diary - how to collect patient data in a smart and modern way
CONTRACT PLACEMENT - ARE YOU LOOKING FOR PEOPLE?
We have gathered some of the most experienced professionals in the business.
Situations can arise in which you want to have a clinical trial carried out, but do not have
the appropriate personnel available. You are then welcome to use one of our consultants.
Our consultants have worked in all possible - and some impossible! - therapeutic areas
and have thereby acquired a large body of knowledge of the pharmaceutical, biotech and
medical device industries.
At Scandinavian CRO, we have scientists and administrators with many years’ experience
in phase I to IV clinical trials in a range of different areas, for example pharmaceuticals and
other medical products, as well as biotechnology and ”Functional Food”. Our contacts range
from global pharmaceutical companies to individual academic investigators and experts.
Being a consultant involves so much! A consultant sometimes needs to have “a foot in
three camps” to maintain a positive balance between the sponsor, the investigator, and
his or her employer. We understand that it can be just as important to fit in as a member
of the team as it is to learn a protocol or data system.
All our employees have fluent spoken and written English, as well as at least one Nordic
language.
INVESTIGATOR SPONSORED STUDIES
Are you a doctor, i.e. an Investigator, who wants to start a clinical trial but needs some sort
of help? We can provide a research nurse at your clinic, help with applications, and/or design the study according to your wishes. Whatever your needs, there are solutions.
An Investigator must have documented knowledge of the rules and regulations of Good
Clinical Practice (GCP) to be authorized to carry out clinical trials on humans. If you or your
staff requires training in GCP, we have the resources to train you according to all the national and international laws and regulations.
Investigator Sponsored Studies can be conducted by university or local governmentemployed doctors, or by those in private practice. The Investigator is responsible for all of
the processes throughout a trial, for example writing the protocol, making submissions to
the authorities, managing documentation, and ensuring that the trial is conducted according to all the relevant laws and regulations. The Investigator is also responsible for any
results published in periodicals.
POST MARKETING STUDIES
Have you been asked to carry out a post marketing study but wonder where to find the
resources? We are happy to help!
When a drug or medical device has been registered with the authorities, it can only be used
for the indication and at the dose registered or the claimed essential requirements. But
surveillance of a new medical product continues even after registration. For example, a
post marketing follow up may be carried out to identify unusual side effects, or to compare
the effectiveness of your product with rivals in a competitive market. Contact us, and we
can discuss what you need!
IT ALL BEGINS WITH
A CONVERSATION.
CONTACT US.
www.scro.se
SCANDINAVIAN CRO AB
Skolgatan 8, Uppsala, Sweden
Phone +46 (0)18 100 550
[email protected] / [email protected]
SWEDEN-NORWAY-FINLAND-DENMARK