Consulting & Specialist Services

To complement the Core Services that Dokumeds offer, our consulting and speciality services cover the gamut of your clinical development and life-cycle needs. From Regulatory Consulting, Feasibility, through Clinical Supply, Logistics, and Recruitment.

Therapeutic Areas

We have an extensive background in a wide range of therapeutic areas, accumulated over the past two decades.Our deepest areas of expertise are Respiratory, Ophthalmology, Oncology, and ardiovascular, and we have extensive experience and expertise in Pediatric Studies. Our high ratio of medics amongst our Clinical Operations staff (over 40%) means we have specialists in most disease areas, and provide through training to staff as they work in each therapeutic area, for the highest quality delivery.

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Feasibility

Dokumeds have been Feasibility Specialists for over 10 years. Sponsors contact us for specialist regional feasibilities, and oversight of global feasibility studies. We performed over 30 dedicated feasibility studies in 2017, assessing regulatory environment and recruitment potential in more than 25 countries. Proof of the quality of feasibility data is in the outcome of the study recruitment.

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Recruitment

Dokumeds has a golden track record in meeting recruitment targets for our sponsors! We pride ourselves in meeting recruitment targets AHEAD of target in more than a third of studies completed between 2015 and 2017. Through our outstanding recruitment record, we have proof in the effectiveness of our feasibility processes.

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Regulatory Consultancy

Dokumeds works with the sponsor to prepare all kinds of regulatory submissions and communications, from CTAs, to MAAs, Scientific Advice, and Over the years, Dokumeds has proven themselves in situations where others weren’t able to meet study quality or milestones obligations. In our rescue studies, we have taken over countries from other regional CROs and bought the recruitment back in line. In other cases, we have increased our recruitment in the countries assigned to us, to make up for shortfalls in other regions. In some cases, we have taken over entire studies from other CROs to rescue both from a recruitment and quality perspective. monitors the regulatory environment on an ongoing basis.

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Study Rescue Recruitment

Over the years, Dokumeds has proven themselves in situations where others weren’t able to meet study quality or milestones obligations. In our rescue studies, we have taken over countries from other regional CROs and bought the recruitment back in line. In other cases, we have increased our recruitment in the countries assigned to us, to make up for shortfalls in other regions. In some cases, we have taken over entire studies from other CROs to rescue both from a recruitment and quality perspective.

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Japan Capabilities

Dokumeds has provided services to Japanese pharma companies continuously since 2003, and has successfully passed multiple audits and inspections from these clients. In addition, we partner with a Japanese site network to run studies in Japan, either as stand alone studies, or part of a larger global study.