Clinical Trials

The pharmaceutical industries of the US and Europe are facing severe financial constraints since the past few years, which are expected to worsen in the coming years. With pressures such as increasing cost of introducing an NME to reach more than $3 billion, tightening regulatory pressures resulting in fewer FDA approvals, blockbuster drugs worth more than $100 billion set to expire by 2014 and drying pipelines of the pharmaceutical industry, cost cutting pressures are mounting on pharmaceutical companies, especially big pharma. These pressures are expected to drive these companies towards low-cost countries to perform their R&D activities, one of their major expenses.

India, over the last decade, has developed significant capabilities in clinical trials, along with certain capabilities in project management and data management. India is able to provide significant cost savings for clinical trials. With discovery research occupying close to one-third of the R&D expenditure for the western pharmaceutical industry, outsourcing to low-cost countries is logical. As the financial and regulatory pressures grow on the US and European pharmaceutical industry, it is expected to further propel the growth in the Indian clinical trial market.

We are the business development adviser for drug discovery, development and clinical trials. We direct scientists, physicians and other professionals to offer these services at research organizations, hospitals and medical colleges. We have contracted a large number of investigators for clinical research project execution. Our objective is to support the desired outcome of clinical trials through expeditious execution at our contracted trial sites around the world in a sustained and globally acceptable manner.

We offer comprehensive suite of clinical services to meet our client's needs. Our most experienced affiliated CROs operate state-of-the-art facilities around the world to offer full clinical trial services to pharmaceutical, biotechnology and devices companies. We would assist you to bring your clinical studies to successful completion quickly and cost effectively. We will be happy to provide detail of our programs, and would welcome the opportunity to work with you. Contact us with any question, comments, thoughts or help.

We are also looking for Clinical Research Business Consultants to get the clinical trial business, coordinate all activities and write proposals/reports. If you know somebody who can contribute to these goals, please let them know about it. E-mail us at clinical@BioBusinessInc.com .

Partnership Opportunty


One of the CRO companies in India, specialized in the IT related areas such as CDM, SAS analysis and up to regularities and filing, is looking a partner company for the following deal. The sponsor is an UK-based medical device producer; plans for a multinational clinical trial involving both EU and US. The product is prosthesis to implant in the recto anal area for fecal incontinence. We need to bring to the table a USA-CRO company that would partner with the India-CRO to make this proposal to UK based client.

Strategy
  • We already have a UK based CRO for EU studies. However, if the US-CRO has already established EU partners and prefers to do the entire study under one umbrella; that can also be accommodated.
  • The US-CRO company must partner with the India-CRO in core competencies.
  • Upon signing of NDA, sponsor will disclose full information that would help better evaluate the study.
  • The NDA agreement draft includes India/USA partnership and it must be signed by both, India-CRO and the US-CRO.

    Study Highlights
  • About 280 patients will be enrolled in 6 US sites and in 6 EU sites. 140 patients will be randomized at study device, 140 at a gold standard device for fecal incontinence.
  • Each patient will be visited at screening, baseline and will be followed for 12 months with 5 visits (at 2 week, 3, 6, 9 and 12 month); after this time, each patient will be visited annually for 5 years.
  • Efficacy and safety end points (to be defined with the Sponsor) will be evaluated at 6 and 12 months.

    Looking for US-CRO
  • What is your Team professional experience with medical device in US?
  • What is your Team professional experience in the field of fecal incontinence?
  • Does your Team perform any clinical trial or clinical protocol for fecal incontinence?

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