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Contract Research Organizations compound in a much more complex area. We assumed because the Phase 3 study was so straightforward, the team could manage both activities at the same time. It was foolish to think that any study is straightforward if people aren���t 100% focused on it. By the time we outsourced it, the study was classified by the lucky CRO that won the bid as a ���rescue.��� not to do. Conversely, we find it is helpful to set the vendor���s expectations on what we are looking for in terms of timing, communication. and written reporting. Our approach to outsourcing can be very hands-on and rather demanding of data, which is not easy for some CROs to deal with, especially if their internal processes are a one-size-fits-all approach. Jim Hauske, Sensor Pharmaceuticals: I always wished I had Katz: I outsourced a very complicated project that required a great outsourced sooner. If the program is successful, the success would deal of training, hand-holding, and explanation. It might have been have been seen at an earlier date, wiser to have insourced the project. and this impacts IP protection. For those failed programs, outsourcing Keller: I selected a CRO that had Big Pharma Sees Benefits sooner will define the failure more a good reputation that I had used To Outsourcing Pre/Clinical Research recently with a good outcome. I quickly and ultimately save money. It will also focus your attention on did not fully appreciate the CRO According to John Hubbard, senior VP and worldwide the next program and, hopefully, a had made some significant internal head of development operations for Pfizer, there are more successful program. organizational changes following a a number of benefits to clinical outsourcing. ���The large acquisition, which changed primary advantage to outsourcing your clinical and Thomas Wessel, M.D., Ph.D, the interface between sponsor and preclinical work is the ability to convert your fixed to Consultant: We attempted to sites. As a result, we had many variable costs. The biopharmaceutical industry has a recruit all patients for a small, early misunderstandings on how fairly high cost of capital due to significant fixed infraspecial pharmacokinetic study at to work together. When we finally structure costs. As the industry seeks to manage the a single academic center. When it determined we needed a reset revenue decline from the loss of exclusivity, many became clear that this center could meeting to revisit responsibilities companies are closing R&D; sites, desupporting legnot deliver the number of patients and delegation of tasks, we came acy IT systems, and reducing geographic footprint. needed within a given timeframe, to the realization that the revised ���Whether you take a staff augmentation approach we decided to work with a CRO that CRO working model no longer or utilize a strategic alliance model, outsourcing prohad experience in this area and to aligned with our needs or way of vides the biopharmaceutical company with flexibility search for other qualified centers. working with investigators. Failure and the ability to leverage infrastructure during this The process of identifying addito assess how the work will be done time of change. In addition, as many large biophartional sites, negotiating contracts, is every bit as important as assessmaceutical companies are re-evaluating their geoand bringing other centers ���online��� ing capability and experience. graphic footprint for conducting clinical trials, CROs would have better been performed offer the ability to maintain a presence in-country by a CRO from the beginning. Wessel: On one occasion, we were disappointed in CRO performance using a more flexible model. In many cases, large DESCRIBE A SITUATION because the initially assigned (and global CROs have a more established presence in WHERE YOU REGRETTED highly competent) monitoring some countries, which allows the biopharmaceutiOUTSOURCING CLINICAL team was migrating to another cal company to establish an above-country model RESEARCH AND WHY? project. Missteps like that can be to operate as a hub working with the CRO partners Green: The situations where we prevented if recognized early and that have operations in those countries. Finally, some regretted working with a CRO typicorrected through communication CROs offer specialized services that can���t or are not cally have come when expectations and collaborative problem solving. cost effective to replicate in a biopharmaceutical or were not set, or at least were not biotech company. Some examples are rater training, WHEN DO YOU FEEL IT IS properly set, at the beginning of interactive voice response services, and imaging MOST APPROPRIATE TO the relationship. Contract research services. As the industry becomes more virtual, OUTSOURCE PRECLINICAL/ labs would be wise not to overstate the need to critically assess internal and external CLINICAL RESEARCH? their capabilities just to get the capabilities for cost effectiveness becomes a critical Dr. Kenneth Burhop, Sangart: contract. We prefer when a lab is component of your overall development strategy.��� When the study falls into the general up front with us about what they category of ���routine��� (i.e. we do not are good at, and what they prefer 12 The CRO Leadership Awards 2013