At INC Research, our therapeutically aligned CNS neurology team are here to help your clinical development program succeed, with our innovative recruitment strategies, deep site knowledge across an array of neurological conditions, and dedicated CNS project managers. Relax, and let our strategic and operational excellence move your compound down the development pathway.
We understand what’s involved in conducting successful Central Nervous System clinical trials. From recruiting the right patients, to making sure their assessments are properly completed by trained experts, to ensuring all stakeholders involved (sponsor, CRO, and vendors) are aligned, we’ve managed these issues across a range of challenging study designs and difficult to recruit indications in neurology. Importantly, we have developed our own strategies and tools to solve problems and keep your study on track.
Our successes will become your successes as lessons learned and best practices are leveraged forward and tailored to your project’s specific needs. From our senior executives through to our CRAs, we specialize in CNS clinical development. That’s how we keep our in-depth knowledge and experience current and fresh. We are not only focused on CNS – we live and breathe it more than any other therapy area.
Helping find suitable patients for your trials
We’re proud to be pioneers in recruiting patients for neurology studies, particularly those that are rare with hard to find patients. We have the experience to find the right patients in key neurological areas of focus, such as Alzheimer’s disease, epilepsy, and Parkinson’s disease, whether they are from an institutional setting, such as a nursing home, living in their own home, or with a family member.
Care settings for patients vary significantly in different parts of the world. For example, in the US it is common for families to provide care for a family member with moderate to severe Alzheimer’s Disease in a nursing home. However, while nursing homes do exist in western and eastern Europe, they are less common, and these patients often receive most of their care at home with periods of hospitalization as needed.
For studies in Alzheimer’s disease, where there is intense competition for patients, it is important to work with a CRO who understands the differences in the treatment settings, and is prepared to help you operationalize a protocol in different regions and still attain a homogeneous patient population. INC have worked in these exact settings and can help you solve these issues.
Even in rare patient populations, our neurology experts will create innovative strategies to help identify suitable patients, using proven, tailored techniques specifically developed for the unique eligibility of the patients needed for the study. By incorporating our dedicated Orphan & Rare Disease unit into our Neurology team, we can work with you to build the best strategic approach as well as tactical implementation to meet your project goals of high integrity data and timely completion.
We’ll take care of complicated logistics
Neurology clinical trials generally require patients to attend assessments such as MRIs, CT scans, PET scans, or EEG. We’ll develop a careful plan with our selected sites to make sure patients get to each of those appointments throughout your trial. A prime example of logistical management can be seen in stroke studies. Some stroke treatments must be given within minute or hours of the event, creating some very challenging logistics for consent, drug supply and administration.
While acute stroke offers these complexities, the logistics are also challenging for post-stroke recovery studies. Patients with stroke are often seen at a minimum of three different care settings over the course of several weeks after the event. From the hospital to the rehab clinic to a long-term care facility, it is important that the logistics to manage the study procedures in each of these settings are arranged in advance, and a specific plan for each patient is created.
It is important that your CRO understands that complex studies like stroke require more than just a standard study plan. INC has the expertise and experience in stroke to help you see these logistical hurdles and overcome them.
Dedicated Project Managers
At INC, we believe that the foundation for study success is strong project management. For us, that means two key things: the first is that all of our project managers reside completely within the CNS business unit and are dedicated to only being assigned to CNS studies. It also means that your study is carefully planned and managed.
Trials in today’s clinical environment are increasingly complex, with more third party vendors to manage than ever before. That complexity means that the CRO cannot manage on a shoestring. At INC, we will ensure effective management by assigning therapeutically focused project managers who also have the expertise to manage the logistics tied to multiple vendors. They take it personally to make sure things run smoothly for you. They’ll keep everyone aligned, and take ownership for the deliverables, successfully coordinating activities with each site and each vendor. Let our project managers take care of it for you.
To find out more about how INC Research is uniquely suited to overcome the challenges of your CNS neurology clinical development, please download our factsheet from the link on the right.
a This is an estimate of INC Research studies from the last five years that are completed or scheduled to complete for this therapy area.