Excellence in clinical research
Our CRO was founded on clinical trial excellence and this remains a central pillar of our project services. We believe that well-planned studies and intelligent data management systems are key to the delivery of superior clinical outcomes. One of the primary reasons for our high rate of customer retention is our outstanding team of Clinical Operations consultants. Our team of highly experienced professionals have joined us from a wide range of Pharma, CRO and collaborative research backgrounds. We take pride in offering the expertise and capabilities you need for the successful development of a new drug or medical device.
Trials delivered with integrity
Our comprehensive CRO services cover the full life cycle of your trial – from initial study design and protocol development, to clinical study reporting and post-marketing activities. Time to market matters, and you can trust us to manage your clinical trial needs in a timely and cost-effective manner. Our efficient eCRF set-up and expert advisors will optimize your study and ensure delivery of high-quality data. In addition, we provide medical writing services and compilation of Data and Safety Monitoring Boards that make the clinical trial process as smooth as possible.
Oncology studies are often complex and challenging, requiring skilled data management and meticulous planning. Our clinical operations team is particularly experienced with oncology trials and the delivery of exceptional oncology data. This is crucial for determining that the right drug at the right dose is used for the right patients. Read more about our Oncology experience.
Whether you are looking for a full-service provider or support with a specific clinical project, we’d like to hear from you. To learn more on how our clinical trials consultants can help you achieve your goals, please contact Marie Moores, at firstname.lastname@example.org.
Overview of Clinical Operations services:
- Study design – Our strategic advisory team will help you choose the best study design in accordance to your regulatory aims and needs.
- Protocol development – We can assist you in developing a comprehensive study protocol and all the supplementary documents required.
- Project management – A dedicated project manager will be assigned to your trial and will be responsible for all activities, from start to finish and through all critical trial phases. Our expertise ranges from small scale first-in-man/proof-of-concept studies to large scale phase III and IV studies. We also have the expertise to carry out your non-interventional and Real World Evidence projects. Read more about our full Project Management services.
- Regulatory development – Navigating complex regulatory requirements is among our core strengths. Submissions to regulatory authorities and ethics committees will be proactively carried out throughout your project. Read more about our full Regulatory services.
- Financial management – Negotiation of site and investigator contracts and maintaining control of study budgets is a key element in ensuring that your trial is completed on time and within budget.
- Country specific trial outsourcing – Our hands-on clinical trial teams are located in Norway, Sweden, Denmark, Germany and the UK. Trials based in other countries can be outsourced from our qualified partners.
- Data and eCRF management – As Master users of the EDC system Viedoc™, our clinical operations team members will ensure real-time data collection and cleaning. Read more about our full Biometrics services.
- Safety and pharmacovigilance – With extensive expertise in pharmacovigilance activities, both national and international, your drug safety reporting needs in clinical trials and post-marketing activities are ensured. We assume all responsibilities, from receipt of initial data to regulatory reporting. Our pharmacovigilance team members are certified users of the EudraVigilance web-based reporting tool (EVWEB) provided by EMEA. Read more about our full Pharmacovigilance services.
- Feasibility and site selection – Finding the right sites and investigators is key to your trial success. With our large network of trial infrastructure, we can ensure first-rate performance. We offer great flexibility and the ability to perform feasibility studies on short notice. We offer recommendations from first-hand experience with the study sites based on your needs and project criteria.
- Monitoring – Ensuring that the investigational protocol is followed, informed consent is correctly obtained, adverse events are reported, accurate records are maintained and study drug or devices are accounted for is imperative to the success of your clinical trial. All members of our clinical operations team have extensive experience in running clinical studies in addition to having solid scientific backgrounds. All our staff are regularly trained in Good Clinical Practice (ICH/GCP), ISO, and other applicable guidelines to ensure quality trial implementation and follow up. Our staff can also be outsourced from your office or as a home-based service.
- Patient recruitment and retention – Recruiting enough of the right patients, and retaining these throughout the study, is key to the delivery of superior clinical outcomes. This is an ongoing process starting with optimal planning and systematic monitoring from recruitment and throughout active study participation, from your first-patient-in to your last-patient-out.
- Medical writing – We offer proficient writing and quality control of your clinical study reports, safety summaries and range of publications. Read more about our full Medical Writing services.
- Training – We provide internal and external training programs in all aspects of clinical study conduct and requirements including GCP and ISO.
- Medical affairs – Once your new drug or device is ready to market, it is crucial to build your brand, your local network, and your customer base. Our Medical Scientific Liaison and Scientific Advisors can assist you with market mapping, product positioning and defining your launch strategies.