Contract Service Provider Alphabetical Listing

Company Name	Description
AIT Bioscience LLC	AIT Bioscience, LLC, headquartered in Indianapolis, Ind., is a bioanalytical contract research organization supporting non-clinical, Phase I through III clinical trials. AIT Bioscience’s mission is to create a new standard for quantitative bioanalytical analysis and drug development in support of small biotech and large Pharma companies. The laboratory was custom-built by industry veterans to support fully automated bioanalytical processes and was furnished with software that capitalizes on the latest technology in the industry. All testing takes place within a paperless environment to avoid the delays and drawbacks associated with hybrid paper/electronic systems, and QA principles are built into every step of the workflow right at the beginning to identify and address potential errors in real time. AIT Bioscience’s goal is to provide you with the testing you need to support your program through to the IND and NDA. Learn more at www.AITBioscience.com or call 800-875-3894. AIT Bioscience is a division of AIT Laboratories (www.AITLabs.com), which specializes in compliance monitoring, forensics, clinical and pharmaceutical testing
AIT Laboratories	AIT Laboratories provides contract analytical services in support of drug discovery and development for the pharmaceutical and biopharmaceutical industries. Specializing in advanced mass spectrometry and immunoanalytical services, AIT is committed to developing new and improved methods to meet the challenging and ever-changing needs of the pharmaceutical industry. AIT utilizes automated specimen management, expert consultation and a rigorous quality assurance system to meet industry challenges while maintaining compliance with ISO 9001:2000, CAP, CLIA and applicable FDA regulations. Almost 20 years of experience in sample management enables AIT to offer the highest quality of organization for the collection, distribution, maintenance and reconciliation of samples from clinical studies. As a premier leader in the application of mass spectrometry for biological samples, AIT routinely develops, validates and performs mass spectrometry analysis in support of new drug development. AIT also offers analytical services, metabolism, biomarker and discovery studies to efficiently fulfill the growing needs of our pharmaceutical partners. Founded in 1990 by Chief Executive Officer Michael A. Evans, Ph.D., AIT is the leading forensic toxicology lab in the nation and also provides laboratory support to health care professionals throughout the nation. Headquartered in Indianapolis, Ind., AIT was recognized in 2007 by Inc. magazine as one of the top 5,000 fastest-growing private companies in the nation. AIT has also received Indiana’s most prestigious technology award, the TechPoint Mira Award.
Aledo Consulting, Inc.	The company provides consulting in the areas of reimbursement and business strategy for medical devices, diagnostics, and pharmaceutical companies.
American Family Pharmacy	AFP provides contract manufacturing services, speciazling is dry dosage forms, packaging, liquid filling and quality control services
Anaclim LLC	Anaclim is a full-service Contract Research Organization specializing in the recruitment of ethnically-balanced populations of patients in clinical trials. By including ethnic minorities to mirror the epidemiologic distribution of diseases being studied, we are able to recruit populations of patients truly representative of the users of the new treatments being developed.
Anson Group	Anson Group provides regulatory consulting services to meet the compliance requirements for product development and marketing including Product Approvals, Quality Systems, Clinical Research and Post-Marketing. Our areas of expertise include drugs, biologics, medical devices and combination products. Anson’s senior staff averages 30 years of industry and consulting experience in fields including regulatory affairs, project management, quality systems, clinical trials, and toxicology. We apply our knowledge and skills to produce results that are aligned with our clients’ business goals.
Baxter Healthcare Corporation	Baxter's BioPharma Solutions in Bloomington, Indiana is a contract manufacturer of parenteral pharmaceuticals with vial and syringe filling as well as lyophilizatio and packaging capabilities.
Bioanalytical Systems, Inc. (BASi)	BASi is a drug development firm providing contract research services and unique products for the pharmaceutical, biotechnology and medical device industries. We provide contract research services under FDA GLP and cGMP quality assurance systems.The company is a leading manufacturer of specialized instrumentation and accessories for liquid chromatography, in vivo sampling (whole blood, plasma, microdialysis and ultrafiltration), veterinary medicine and electrochemistry. Our services and products have been well received in drug metabolism research, pharmacokinetics studies, pharmacology, toxicology, pharmaceutical product analysis, stability program support and veterinary health.
BioConvergence	BioConvergence is a contract solutions firm for the pharmaceutical and life sciences industry. We provide product development, GMP supply chain & materials management, toxicology and clinical materials manufacturing and packaging, QC testing and a new biorepository and clinical sample management service as well as consulting services for our clients across the globe. We value serving our clients with quality, reliability, responsiveness, innovation, transparency and speed. Let us help you develop, test, produce, and supply your small or large molecule compound to get you to market faster!
BioStorage Technologies Inc.	BioStorage Technologies, Inc. is a worldwide leader in sample storage, inventory management and cold chain logistics for the biotechnology and pharmaceutical industries throughout the research, clinical trial and commercialization phases of drug development. The company offers secure, temperature-controlled storage; real-time tracking of stored biological samples; and next-day return of biomaterials. BioStorage Technologies is privately held and headquartered in Indianapolis with an additional full-service site near Frankfurt, Germany.
Chemical Genomics Core	The Chemical Genomics Core Facility (CGCF) at the Indiana University School of Medicine (IUSM) was established in the summer of 2005 at the Department of Biochemistry and Molecular Biology. It is located at the Medical Science building of the IU Medical Center. CGCF is directed by Dr. Zhong-Yin Zhang, the chairman of the Department of Biochemistry and Molecular Biology. The core provides cost-effective access to high throughput screening (HTS) of structurally-diverse, drug-like small molecules in biological assays provided by the investigators. This would enable the investigators to discover small molecule tools for basic research, therapeutic development and diagnostic applications. The core facility incorporates state-of-art automated instrumentation, a total collection of 160,000 small molecule compound library, computer database, and a staff experienced in assay development, high throughput screening and laboratory robotics. The core facility is a service and collaborative research resource where facility staff works closely with each investigator through all stages of the screening process. In the near future, the chemical genomics core facility will further develop its medicinal chemistry capabilities for targeted chemical synthesis, which will be dedicated to the optimization of lead compounds discovered from the HTS in order to enhance therapeutic properties of the lead compounds, including potency and selectivity, as well as bioavailability and toxicity.
Chemical Synthesis & Organic Drug Lead Development Core	Given the increased demand for customized chemical syntheses of drug leads and biological probes on the IUPUI campus, the Department of Chemistry & Chemical Biology of the School of Science has joined forces with the IU Simon Cancer Center (IUSCC) to create a core facility for Chemical Synthesis & Organic Drug Lead Development to expedite the translational research and drug development efforts of cancer researchers and others. The goal of the Synthesis Core is to support the synthetic and medicinal chemistry needs of IUSCC investigators as well as other academic entities within IUPUI and throughout the state; the core is also available to the broader life sciences industrial community of central Indiana and elsewhere on a contract basis. The core is directed by Dr. Eric C. Long, Professor & Associate Chair of the Department of Chemistry & Chemical Biology within the School of Science while the core is managed by the Director of Synthesis, Dr. Tax Georgiadis. Dr. Georgiadis is a synthetic/medicinal chemist with greater than 20 years of experience in both industrial and academic settings. The services currently offered by the core include: Custom Syntheses of Investigator-Requested Compounds including literature-cited compounds, patented agents, compounds discovered through high-throughput screening, experimental agents, and focused libraries and Medicinal Chemistry Support such as assistance in achieving improved ADMET (adsorption, distribution, metabolism, excretion, toxicity) properties of lead compounds to improve biological activity, lead optimization (SAR analysis), database searching and data mining of drug discovery targets, insight on the patentability of chemical matter, and chemical informatics. http://www.chem.iupui.edu/Facilities/core/index.php
Commissioning Agents, Inc.	CAI provides cGMP Commissioning, Qualification and Validation as well as Project Management and CSV services to Pharmaceutical and Biotech manufacturing labs and facilities delivery.
Cook Pharmica	Cook Pharmica, contract biopharmaceutical manufacturing division of Cook Medical, offers a complete line of contract manufacturing services, from development to CGMP manufacturing of mammalian cell culture-based biopharmaceuticals. Services include development support, CGMP cell banking and storage, analytical testing, CGMP manufacturing, and stability storage and testing. Current CGMP manufacturing capacity is sized for clinical and small-scale commercial runs with two 2500L bioreactors. Development services include cell/strain development, single cell cloning, media optimization, process development, creation of non-CGMP cell banks, analytical development, and method validation. Cook Pharmica is well positioned to expand capacity and capabilities to meet their clients’ needs.
DCL Medical Laboratories, LLC	Medical Laboratory
Elona Biotechnology, Inc.	Contract Research and development company specializing in proteins. We do protein purification, process development and preparation of clinical trial material. We are developing a small scale commercial manufacturing facility to produce several protein product for clients. We have developed IP for generic biologics to make them significantly cheaper than current processes
Fairbanks Institute for Healthy Communities	The Fairbanks Institute for Healthy Communities is a not-for-profit organization working to improve community health by creating INbank™, a next generation biorepository for discovery and validation research. INbank™ connects information available in patient histories and clinical outcomes data with meticulously collected and broadly consented biological samples collected in longitudinal cohort studies of the Central Indiana population. INbank™ will enable research that may lead to more effective personalized medicines and better health for generations to come. The Fairbanks Institute was created with seed funding gifts from the Richard M. Fairbanks and Guidant Foundations in collaboration with BioCrossroads, the Regenstrief Institute, the Indiana University School of Medicine and other Central Indiana community partners.
G & S Research, Inc.	G & S Research provides difference-making market research to healthcare decision-makers. With inside experience at top pharmaceutical and biotechnology companies, G & S Research helps clients engage internal groups in the research process and influence brand strategy with results. Visit www.gs-research.com for details.
Harlan	Global provider of research tools and services that enable innovative and efficient discovery and development in the pharmaceutical, biotechnology, agrochemical, and chemical industries.
Indiana Department of Workforce Development	The Indiana Department of Workforce Development offers an array of training grants to Indiana businesses to enhance the skills of their incumbent workers.
Indiana University School of Medicine	The Indiana University School of Medicine is the nation's second largest medical school. The school holds more than $220 million in research grants and contracts and hosts federally designated centers of excellence in cancer, kidney disease, Alzheimer disease, alcohol research, arthritis, sexually transmitted disease centers on both the pediatric and adult levels, and women's health. The affiliated Regenstrief Institute is an international leader in medical informatics. Research cores with expertise in such technologies such as proteomics, genotyping, protein expression, high resolution microscopy and in-vivo imaging provide services to academic and private sector scientists. The school fosters an enterpreneurial culture and is producing growing members of intellectual property disclosures. IUSM has more than 1,300 medical and graduate degree students with education and research programs at eight regional campuses in addition to the Indianapolis campus. There are more than 1,400 full and part-time faculty, 22 research centers and institutes and 19 research cores. More than 760,000 square feet of new research space has been built since 2000 or is under construction.
Indiana University School of Medicine / Indiana Institute for Biomedical Imaging Sciences	Academic Imaging Institue with molecular, functional, and anatomical imaging capabilities in pre-clinical and clinical imaging capabilities
Indiana University Vector Production Facility	Thank you for your interest in the Indiana University Vector Production Facility (IU VPF). The IU VPF is located on the Indiana University Medical Center Campus, part of Indiana University-Purdue University at Indianapolis. The IU VPF is a laboratory within the Indiana University School of Medicine and the Department of Medical and Molecular Genetics and is dedicated to the development, production and testing of gene therapy technology. The IU VPF is directed by Dr. Kenneth Cornetta, the Chairman of Medical and Molecular Genetics and the Vice President of the American Society for Gene Therapy. The production facility contains two production suites which are dedicated to specific vector systems. One suite is used to produce retroviral vectors and the other is used to produce lentiviral vectors. In addition to the production services, the IU VPF offers a wide variety of routine and specialized assays important in safety testing and certifying both clinical and non-clinical grade vectors. Vector titering is available using cell culture, while FACS, PCR and quantitative PCR assays are available to accommodate a wide variety of vector constructs. Quantitative PCR is also available to measure transduction efficiency in-vitro and in-vivo. Click here for a complete description of services. To date, the IU VPF has certified over 30 vectors for clinical trials throughout the United States and abroad.
Indiana University-Purdue University Indianapolis	Indiana University-Purdue University Indianapolis (IUPUI), since 1969 a partnership between Indiana University and Purdue University, is Indiana’s urban research and academic health sciences campus. With nearly 30,000 students taking advantage of a distinctive range of cutting-edge degree options, the campus seeks to meet the needs of the 21st century workforce, especially in the biosciences, and advance Indiana through educational, cultural, and economic development. Strong commitments to innovation, collaboration, and diversity fuel a unique mix of interdisciplinary, practice-based education and research that attracted more external grant dollars to IUPUI in 2006-2007 than to any other Indiana campus. At the undergraduate level, the campus is nationally recognized for the quality of its first-year experience programs, service learning, and undergraduate research opportunities.
Innovative Clinical Concepts,LLC	ICC is a Site Management Company with special CRO capabilities focused on recruiting minority community based physicians who have large minority patient populations to participate in clinical trials.
inVentiv Clinical Solutions	At inVentiv Clinical Solutions, we understand the increased regulatory and financial pressures faced by the biopharmaceutical industry today. That’s why we offer comprehensive, flexible services including clinical trial management and monitoring, data management, biostatistics, medical writing, regulatory consulting and liaison services and patient and investigator recruitment. These services are complimented by traditional clinical staffing capabilities through our industry leading staffing divisions, MedFocus and Smith Hanley Consulting Group. As a division of inVentiv Health, Inc. (NASDAQ: VTIV), we have the unique ability to leverage resources from clinical to communications and commercialization to build cutting edge, end-to-end solutions for our clients.
Ivy Tech Community College	Ivy Tech Community College is the nation’s largest statewide community college system and Indiana’s second largest public post-secondary institution with more than 110,000 students enrolled annually. Ivy Tech has 23 campuses throughout Indiana. It serves as the state's engine of workforce development, offering affordable degree programs and training that are aligned with the needs of its community along with courses and programs that transfer to other colleges and universities in Indiana. It is accredited by the Higher Learning Commission of the North Central Association of Colleges and Schools.
JLM Pharmatech	A manufacturer of tablets, coated tablets, capsules, coated capsules, and packager of solid dosage forms. Producer of the raw materal Polysaccahride Iron Complex.
Krauter Solutions	Design/engineering and turn-key installation of cold storage and materail handling (pallet racks, etc.) for Life Sciences, from Laboratory cold rooms to warehouses for Logistics, Distritbution and raw materials.
MD Logistics, Inc.	Third party life sciences logistics company
MED Institute, Inc.	MED Institute, Inc. was incorporated in 1983 to identify and develop new medical product concepts. From investigating a new concept to product marketing, MED provides a continuum of services to support the medical product manufacturer. In the product development process, MED Institute offers research, product design, prototyping and testing (feasibility and GLP) needed for the evaluation of new products. MED laboratories include a technology assessment lab, an advanced histology lab and biomechanical fatigue analysis lab. MED also coordinates clinical research worldwide and FDA and foreign regulatory approvals. Medical technology transfer through scientific presentations and product publications, product information, and technical training are central to high technology product development at MED Institute. MED Institute was established as a resource for COOK Group companies to identify and develop new medical product concepts. This includes new product identification, prototype development, nonclinical Good Laboratory Practice testing, clinical trial management and data analysis, education for the medical community, and preparation of regulatory submissions. MED Institute employs a staff of research, medical, engineering, and technical personnel or professionals. MED Institute has established a Quality Management System that has been certified to ISO 13485 and conforms to ISO 14155. In addition, the MED Institute Laboratory has a number of tests accredited to ISO 17025 (see web site for details)
MicroWorks, Inc.	MicroWorks is a contract firm specializing in Microbiology. We do consulting, training and testing for pharmaceutical, medical device and biotech firms.
Midwest Compliance Laboratories	Midwest Compliance Laboratories is a newly formed company that is planning to begin their service offerings to it's phamaceutical, food, and nutraceutical clients beginning in January 2009. Our company was created by a group of experienced chemists and microbiologists poised to offer contract laboratory services that include traditional testing of raw materials, pharmaceutical intermediates and drug products in a GMP/GLP compliant environment. In addition to these basic services, our company is also offering advanced analytical techniques for trace analysis and characterization of foreign matter via the use of ICP/MS and SEM. It is MC Laboratories specialty to perfect the methodologies employed by these techniques and translate them into useable QC Methods to be utilized for routine analysis. In addition to our laboratory service offerings, we can also offer consulting services that include laboratory auditing, SOP development, technical transfer, method development, and validation support. Our company was founded by professionals with decades of experience in the industry that have a deep desire to carry-on their tradition of providing high quality laboratory support to their clients.
Midwest Institute For Clinical Research	MICR® is a dedicated clinical research site, established in the summer of 1988 to develop and implement clinical trials (Phase II-IV) in the Indianapolis metropolitan area. With nineteen (19) years of experience and 385 protocols, our program is dedicated to provide the highest quality service to the pharmaceutical and medical device industry as well as to the volunteers who participate in these clinical trials.
Pharmakon Compounding	Pharmacy specializing in manufacturing of compound sterile products and repackaging of drugs following GMP as defined by the FDA code of federal regulations.
PreClinOmics, Inc	PreClinOmics, Inc is a contract research organization based in Indianapolis, IN. Our goal is to provide our customers with the services they need to progress their drug development efforts. PCO is an AALAC Accredited, GLP facility that supports research including: screening, pk, efficacy/pd and toxicology. Incorporated in 2001, PCO has worked with many different clients in the pharma industry from the large corporations to the virtual start-up.
Purdue University	Purdue University has a history of providing strong internship and co-op programs, working with companies throughout Indiana in many aspects of biology, chemistry, bioengineering, analysis, drug formulation, life sciences research projects dealing with fundamental biology, fundamental chemistry, pharmaceutical delivery, manufacturing and other areas. Purdue works with Indiana companies and strives to be a supportive resource for the biopharma industry through the National Institute of Pharmaceutical Technology. NIPTE's goal is to become the preeminient interdisciplinary national resource for research and education for providing a science-and-engineering based understanding of pharmaceutical development and manufacturing. Scientists, researchers and engineers from academia, the FDA and the industry will collaboratively engage in developing state-of-the-art science and technology to enable the pharmaceutical industry to develop products faster, and at a significantly lower cost with less variability and higher predictability of performance.
Purdue University - Department of Industrial and Physical Pharmacy	Department of Industrial and Physical Pharmacy at Purdue University is dedicated to teaching, research, and service in all areas of pharmaceutics.[http://www.ipph.purdue.edu/] As a member of the department, my research interests are in translational research, biopharmaceutics/pharmacokinetics and pharmacodynamics.
Safis Solutions, LLC	Safis Solutions, LLC is a regulatory compliance consulting company serving pharmaceutical, medical device, diagnostic and biotech companies worldwide to ensure health authority requirements are met. Areas of expertise include regulatory approval, clinical strategies, quality systems, validation, IT services, auditing, and post-market surveillance programs.
Sentry BioPharma Solutions	Sentry BioPharma Solutions provides dedicated GMP storage, logistics, packaging, kitting, labeling and distribution services for the pharmaceutical biotechnology and health care industries.
Sigma-Tau Pharmasource	Sigma-Tau PharmaSource, Inc. is a biopharmaceutical contract manufacturer specializing in complex injectable formulations, including liposomal drug delivery technology and PEGylation. Our mission is to provide flexible, responsive services and innovative solutions to our clients.
SSCI, an Aptuit Company	SSCI, an Aptuit company, offers cGMP contract solid and liquid phase development services for the pharmaceutical industry. We focus on understanding, improving, and protecting your active ingredients, formulated products, and intellectual property. Through polymorph, salt, cocrystal, amorphous material, and analytical method development research we have been able to dramatically improve our clients' outcomes in development while at the same time building a sound intellectual property position. The Aptuit Company as a whole focuses on reengineering the drug development process. We apply a completely different mindset to the drug development industry, offering a modern business strategy aimed at revolutionizing the entire process, from drug discovery through commercialization. We are the first provider to combine industry-leading drug development consulting expertise, state-of-the-art GMP/GLP facilities, innovative technologies designed specifically to expedite the development process, complete project management capabilities, and comprehensive regulatory compliance services, all in one package. Customers can select distinctive parts of the mix, or an end-to-end solution. Currently, we provide a comprehensive suite of drug development services and competencies to more than 600 pharmaceutical and biotechnology companies worldwide.
Stanbio Life Sciences	Stanbio provides contract microbial fermentation and bioprocessing services to the biotechnology and pharmaceutical industries. We offer broad expertise in process development and optimization to support process transfer and scale-up for our clients. Stanbio has a proven record of meeting client needs in a cost-effective and timely manner. Our facility is cGMP for the medical device industry and we are ISO13485 compliant. Stanbio additionally manufactures proprietary reagent enzymes for the diagnostics industry.
Vesta Pharmaceuticals Inc.	A leading full-service pharmaceutical and nutraceutical contract manufacturing company, offering ANDA registration services, and regulatory consultation services.