BD Food Safety Consultants LLC

Our vision is to conduct clinical trials better and more cost effectively than anyone else. We accomplish this by working with our clients to not only deliver the clinical trial effectively, on time and within budget, but also by leveraging our in-depth expertise to ensure the clinical trial is properly designed.

We believe there is increasing need for innovation, creativity and scientific expertise in clinical research, characteristics often synonymous with small Biopharma and hence, though we are proud to have a number of the world’s largest pharmaceutical companies as our clients, greater than 80% of our client portfolio is small Biopharma.

ACLIRES has performed trials for an international array of biotech companies as well as for some of the largest global pharmaceutical companies. With our broad access to patients and expertise, our aim is to rapidly initiate our client’s studies, even when a very special patient population is required.

Our services include:
- Early Phase Studies
- Late Phase Studies
- Recruitment
- Regulatory Affairs
- Monitoring
- Site Selection
- Scientific Services/Medical Writing
- Consulting
- Quality Management

As consultants for the pharmaceutical, biotech and device industries we know that teams assembled around product development and clinical trials need more than a competent project manager and top technology to be successful at delivering according to plan.

To be successful, project teams in the health industry need a leader, with a strong medical and industry background, that will inspire, coordinate their efforts, and act as a single point of contact or reference for all involved; sponsors, sites, CROs, data & safety monitoring committee, clinical endpoint committee, special labs, IRB, FDA.

Anabase, founded by two MDs with both clinical practice and industry experience, provides independent, dedicated, hands on, medical and regulatory guidance to your product development and clinical trial projects.

bioaccess™ is a US-based contract research organization (CRO), regulatory, and market access consulting company that delivers a full spectrum of offerings from bench to commercialization so that foreign biopharma and medical device companies can have long-term success in Colombia and the rest of Latin America.

FIRST-IN-MAN CLINICAL TRIALS, MARKET ACCESS, MARKET ENTRY, INVIMA REGULATORY CONSULTING, AND LEGAL REPRESENTATION IN COLOMBIA FOR INNOVATIVE MEDICAL DEVICES AND OTHER ADVANCED MEDICAL TECHNOLOGIES.

Our promise is for foreign medical device companies that believe that Latin America offers untapped potential to conduct trials and sell their products. We focus on forward-looking medical device companies that want to run a first-in-man clinical trial and want to have long-term sales growth in the region. We promise that by engaging with us as your CRO, regulatory, or market access consultants, your company will cost-effectively get the clinical data it needs or will be able to increase its sales in Colombia and the rest of Latin America.

Foreign medical device companies struggle to find a cost-effective clinical trial site or to gain market share in Latin America. They are unfamiliar with Latin America and lack in-house experts who can operationalize successful clinical research, regulatory, or market access strategies in Colombia.

ClinSmart is a contract research organization based in Bucks County, Pennsylvania. We offer personalized, comprehensive clinical development services with an experienced and dedicated staff.

You can count on our team of industrial and academic professionals to manage key aspects of your upcoming trial. Our service offerings include:

• Drug safety
• Regulatory
• IND preparation
• Clinical strategy
• Project management
• Biostatistics & programming
• Site management
• Data management
• Medical writing

Our goal is to assist you to properly plan and execute your clinical strategy to assure early FDA approval and expedite your product to market.

Clinstat Consulting was founded in 1999 by Patricia Hamilton, RN, MS.

Patricia is a clinical expert with over 25 years experience. She is a Registered Nurse and holds a Master's Degree in Business Management. She has had extensive senior level technical and management experience delivering clinical research plans and studies on time and within budget for Fortune 500 global corporations as well as for small companies and start-ups. She has set up and managed clinical departments from the ground level and has hands on experience in all phases of developing a clinical/regulatory strategy, securing investigators, site selection, protocol development, site monitoring, generation of final reports and writing FDA submissions. Patricia and her staff are well suited to guide start-up companies or assist established firms with any or all your clinical needs.