[ Edit this Company ] Company Profile for Stark-SMO Inc. Company Name: Stark-SMO Inc. Address: 38 Miller Avenue PMB 170 City, State, Zip: Mill valley, CA 94941 County: United States Country: US Phone: 415-888-3700 Fax: 415-888-3600 General Email: davidlstark@comcast.net Web Site: http://www.stark-smo.com Brochure: Keywords: SMO, Stark-smo, Research, Pharmaceutical, Clinical Trials, Trials, Site Management organization, Site training, Good Clinical Practices Training, GCP, Clinical Research, Research, Phase I, Phase II, Phase II, Phase III, Phase IV, Research education, Research Training, investigator training, Drug research, Drug trials, investigators, Clinical, Device Company Description: From the pharmaceutical and medical device manufacturing trials, through FDA IND or IDE submissions, and beyond-guiding your clinical trial through the IRB review process, study management, and monitoring phases, we are there for you every step of the way, with expert advice and services that can save your company time and money. Services Offered: We present pre-screened investigators and coordinators to site locations throughout the country, thoroughly educating both in a comfortable, on-site context. These people are experienced, qualified professionals who meet specific standards before admission into the network. With more than 15 years of experience, Stark SMO recognizes and resolves costly trial issues early on, leading to higher-quality study compliance and cleaner outcomes. We conduct each trial under strict adherence to FDA GCPs, and are dedicated to a high level of protocol compliance, along with responsive communication paths among sponsor, site, IRB, study personnel and related trial entities. Finally, every member of Stark SMO is experienced in net-based data capture. About Us: Our connections, communications, and experience all work together to make your clinical trial run more smoothly. One example is our professional relationship with a commercial IRB, Independent Review Consulting. Knowing what the IRB wants is the fastest way to avoid review problems. Differentiation: Stark SMO is an innovative Site Management Organization that has experience in all phases of clinical trials. We are an SMO that can improve the outcome of Phase I clinical trials. Our proven training methods can cut down on adverse events and protocol deviations. We believe that improving the training in Phase I clinical trials can improve the safety factors. We are a Site Management Organization that takes safety seriously. Stark SMO can also apply its proven training and organization methods to Phase II clinical trials. This is a critical stage for many research companies. A Phase II clinical trial is often where a pharmaceutical or medical device company finds out if its product is viable. We believe that the right SMO can make a big difference in a Phase II clinical trial. Organization and training are very important. Stark SMO has a nationwide network of trained and qualified investigators at the ready. These are investigators who are serious about clinical research. Sometimes a SMO can simply sign up their investigators without even knowing what they look like. All of our investigators have been trained in Stark SMO methods and are ready to serve as professional research sites for your pharmaceutical or medical device clinical trial. Having many research sites at the ready is important for Phase III clinical trials. The large number of subjects to be enrolled in a Phase III study means that a SMO has to be prepared to mobilize its clinical research sites very quickly. We are a Site Maintenance Organization that prides itself on how rapidly we can mobilize for a Phase III clinical trial. Our many and varied talents can even help to design recruitment methods and strategies. We can even write and illustrate recruitment materials to customize them for your Phase III clinical trail. Many pharmaceutical and medical device companies are now exploring the unique and effective marketing strategies of Phase IV clinical trials. Bringing a new pharmaceutical or medical device product to market through the clinical trial route is no longer enough. Stark SMO has a working relationship with a commercial IRB that is very experienced with late phase or Phase IV trials that are designed as a registry. Let us show you how Stark SMO methods can benefit your Phase IV needs. Ours is a Site Management Organization whose capabilities go far beyond that of an ordinary SMO. Having an established and professional relationship with an IRB or Institutional Review Board is just one of the many unique benefits that Stark SMO can bring to your clinical research endeavors. Many clinical studies get bogged down at the IRB review stage because the SMO does not know how to deal with the IRB. All of the professional research specialists who work for Stark SMO have been involved with an IRB at some point in their careers. This brings an important perspective to clinical trial management. Stark SMO has many resources available for your Phase I clinical trial. We can help with the critical challenges of Phase II studies. We can mobilize quickly for Phase II trials. And our innovative methods make Phase IV trials more efficient and profitable. Products Offered by Stark-SMO Inc.  No products have been listed by this company. Services Offered by Stark-SMO Inc. Service Name Service Description Service Keywords D B WWW 1 FDA Reg.. 510 K application, PMA, Protocol devlp. 510k, PMA, Protocol Design/writing, IRB filling, FDMA meetings, early collaboration meetings, DMF, QA, QC, SOP's and API development and much more. We can help with each step, along any FDA road for approval. FDA, Regultory, 510K, PMA, Pre IDE submission, determination meeting, agreement meeting IDE, Market approval and research development, protocol writing, statistics, IDE, clinical trials, research development. FDA, FDAMA D WWW Additional Contact Information for Stark-SMO Inc. Sales Contact: Stark-SMO Inc. Sales Phone: 415-888-3700 Sales Email: davidlstark@comcast.net Executive Contact: David Stark Executive Title: President Executive Phone: 4158883700 Executive Email: davidlstark@comcast.net [ About ] [ Contact ] [ Login ] © 2025 Medevnet.com - All Rights Reserved