The landscape for biosimilars is dynamic and quickly changing. As a result of the speed of change, clinical programs must be created to meet the most recent standards in the targeted markets. It entails adjusting to operational difficulties caused by a challenging patient recruitment environment, competition from other biosimilars, and new drug developments. For regulatory and business success, it is essential to collaborate with a multidisciplinary, experienced biosimilars organization.
Our Biosimilar Consortium, a group of seasoned professionals from various fields, is available to assist you in navigating regulatory challenges and choosing the best nations and locations for on-time patient recruitment. This assistance is crafted in the best commercial strategy for the most effective market access and commercialization worldwide.

Nearly 50 clinical biosimilar studies have been conducted, with more than half being international.

CGT is a brand-new front in the battle against a variety of deadly illnesses, such as rare genetic abnormalities and some malignancies. It also presents particular difficulties for the researchers and businesses that are pioneering this potentially game-changing research as well as for the patients and families who are taking part in it.

Clinical trials for CGT typically have complex study designs, difficult patient populations, and unique operational delivery constraints. Many times, patients, site staff, and investigators are all unfamiliar with new treatment methods. The long-term follow-up necessary to identify, document, and effectively manage signals of early or delayed adverse reactions as well as to support pricing and reimbursement, a time period that frequently coincides with CGT trials, is just one of the many complex logistical considerations that CGT trials present.

Utilizing the clinical and commercial skills of XEsearch Research, we bring together therapeutic knowledge, patient advocacy, narrative, behavioral science, patient reported outcomes and registries, compliance, and health policy ability to advance patient perspectives in innovation.

True “patient voice” is only now being acknowledged as a valuable resource in the development of medications as a result of persistent patient lobbying and regulatory initiatives.

A long-standing communication gap between patients and those who innovate on their behalf is now starting to shrink as the patient voice grows.

The development of products for the pediatric patient population has unique requirements and considerations, such as involving patients and their parents or guardians in the research study process, placing a high priority on ensuring the safety and well-being of this vulnerable population, dealing with the complex regulatory and commercial environment that is related to children, and taking into account the fact that the pediatric patient population is not one specific age group but rather consists of several age groups with different needs. You must collaborate with a skilled, multidisciplinary, cross-functional team that is passionate about the needs of children and the creation of therapies for them in order to successfully meet these obstacles.

There are highly particular difficulties in the area of clinical development and commercialization for rare diseases. For patients with a rare disease, innovative solutions are needed to give quick access to treatment alternatives. Patients, advocacy organizations, key opinion leaders, payers, and regulators are just a few of the stakeholders that must be taken into account while establishing a plan.
Future post-marketing and commercialization considerations must be taken into account in specific regulatory strategies for the clinical development of rare diseases. With the help of our improved capabilities, we successfully integrate these requirements and create and put into practice efficient, worthwhile solutions for our clients that reduce the time it takes to go from the lab to real life.

We have assembled a versatile team of experts, including those in the field of rare diseases, to use our extensive experience in rare illness clinical development and post marketing requirements.