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Orphan Focus

Healthcare companies with rare disease focus are relying on outsourcing like any other company involved in the product development and commercialization of new medicines.

Whereas today biopharmaceutical companies operating in the common disease field can refer to a broad base of full-service providers, it becomes difficult to select appropriate providers that can address the particular challenges that rare diseases entail. There is also no service solution available that addresses all aspects and offers a holistic approach to the particularities of dealing with orphan drugs keeping the patient in mind at the centre of all activities.

orphan reach are in business to provide the biopharmaceutical industry with the ultimate product lifecycle solution including clinical support and integrated patient management.

The purpose of orphan reach is to expedite the development of orphan drugs and facilitate patient access to treatments which can improve the quality of life of patients and patient’s families. By driving best practice we can provide continued, seamless, high quality support to biopharmaceutical companies throughout any stage of the orphan product lifecycle, a service that has not previously been available.

Being able to navigate the orphan regulatory landscape is important. Defining a clear direction from the outset is essential as time and money are of a limited nature.

Our teams are highly experienced to advise our clients in the following areas:

Regulatory Strategy Planning

Orphan Designation Applications

Break Through Designation Applications

Orphan drug designation

Pediatric Priority Review Vouchers

FDA and EMA Meeting Preparation and Representation

Patient Advocacy Group strategic planning

Our services are tailored to accommodate clinical trials globally involving small patient numbers and to deal with the particular medical, scientific, clinical and commercial challenges within the rare disease domain.

The traditional global CRO model is tailored to manage large numbers of patients. The business and operational model of global organisations relies on substantial infrastructure to support these activities. A big part of this infrastructure consists of local subsidiaries that have historically been set up wherever clinical trials take place.

orphan reach employs a strategic partnering model. Read More

We foster close relationship to key opinion leaders, to ascertain real-life experience and involve them very early in the development program. We train and educate investigators and lead initiatives to improve disease awareness. We link with patient advocacy groups and obtain valuable input from patients themselves. We establish a patient recruitment plan and explore patient registries and referral sites. We proactively collaborate with health authorities early in the development program.

We nurture excellent global contacts with Clinical Research Networks, indication specific Investigator Networks and Patient Advocacy Groups. We also engage referral sites, pre-identify patients at site and use relationship marketing experts. Combining the various measures in an effective way helps us to meet or exceed patient inclusion timelines.

With very few patients, the integrity and completeness of data from each patient assumes even greater importance. We employ many methods, including the following to retain patients and maintain compliance. Focused training of sites and patients is provided to increase retention and compliance supported by experienced Senior Clinical Research Associates at a site level. Engaging patient advocacy groups, providing home healthcare by trained nurses and patient travel logistics support are all additional efforts to ensure a smooth data collection according to the planned study timelines. Read More

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