Contract Service Provider Alphabetical Listing

Company Name	Description
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 parenteral product development, GMP supply chain & materials management, toxicology and clinical materials manufacturing and packaging, QC testing and consulting services for our clients across the globe. We value serving our clients with quality, reliability, responsiveness, innovation, transparency and speed.
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.
Centurion Clinical Research, LLC	Centurion Clinical Research is a Contract Research Organization devoted to the planning and execution of Phase I and II Human Clinical Trials.
ChemiGen	ChemiGen is a contract research facility offering lead generation, optimization and preclinical validation services to select partners wishing to outsource these functions to increase capacity, reduce costs and gain access to high technical proficiencies.
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.
Covance, Inc.	Covance — one of the world's largest and most comprehensive drug development services companies — has the people, global resources and problem-solving culture to respond to pharmaceutical and biotechnology clients' toughest drug development challenges. We provide a portfolio of preclinical and clinical development and commercial service offerings — delivered through industry-leading nonclinical testing services, the world's largest central laboratory network, and a global team of clinical trial professionals.
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
Enzon Pharmaceuticals, Inc.	Enzon Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the development, maufacturing, and commercialization of important medicines for patients with cancer and other life-threatening conditions.
ExaroMed, Inc.	ExaroMed, Inc. is a premier medical communications, marketing, and strategy implementation firm based in Carmel, IN. We work as a strategic partner with our clients to create and execute content development strategies to meet their marketing and educational communication objectives.
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	inVentiv Clinical Solutions is the alternative to traditional clinical outsourcing, allowing the greatest control and flexibility through unmatched access to high quality clinical resources. As a strategic partner, inVentiv Clinical Solutions provides clinical trial management and monitoring, data management and biostatistics solutions, 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 also bring clients a wide range of clinical, sales, marketing and communications solutions.
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.
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.
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 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.
Monarch LifeSciences, LLC	Monarch LifeSciences is a contract research organization providing services in protein biomarker discovery, development and validation. Monarch’s biomarker discovery services include experimental design, proprietary sample preparation methods and quantification algorithms to ensure the generation of quality data. The LifeMarker™ Assay provides accurate high throughput analysis of proteins without the need for an antibody.
OBS Medical (Oxford BioSignals)	OBS Medical is based in Carmel, Indiana and provides innovative clinical algorithms for safer hospitals, safer patients and safer drugs. Based on intelligent algorithms such as neural networks, data fusion and ECG waveform recognition, OBS Medical technologies cover a range of medical applications including automated early crisis warning (Visensia™), automated assessment of ECG waveforms and intervals (BioQT™), and EEG analysis for brain-state assessment. OBS Medical is a wholly-owned subsidiary of Oxford BioSignals Ltd. based in Oxford, UK, which was originally spun out from Oxford University.
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.
Project Technologies, Inc.	Provides project management, engineering and equipment/facility qualification and validation services for capital projects in the pharmaceutical, biotech and related industries.
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 Logistic Solutions	Sentry Logistic Solutions provides dedicated GMP storage, logistics, packaging, kitting, labeling and distribution services for the pharmaceutical biotechnology and health care industries.
Seradyn, Inc. a subsidiary of Thermo Fisher Scientific	With over 20 years of microparticle experience, Thermo Fisher Scientific Indianapolis provides innovative solutions for the world's best medical, diagnostic, and life sciences companies. We have built a reputation as a world-class manufacturer of many OEM assays and highly specific particles for the largest companies in the world. We are committed to your success by providing raw materials and the timely technical support you require. With over 20 years of experience in providing solutions for the world's top companies, we continue to set the standard for the development and manufacture of microparticles and OEM immunoassay products. We are focused on a range of therapeutic drug monitoring homogeneous immunoassays utilizing multiple analytical technologies. Our assay technologies include turbidimetry, fluorescence polarization and chemiluminescence. Our products are sold by OEM arrangements and through distributors throughout the world. We also focus on microparticles used as a raw material for these clinical immunoassays and molecular biology applications. The microparticles are used in a wide variety of diagnostic assays, as well as nucleic acid isolation, amplification, genotyping and sequencing applications. We further enhance our value to our partners by supplying monoclonal antibodies and recombinant antigens.
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.
The Chao Center	A small contract manufacturing organization dealing with non-sterile dosage forms from oral and topical applications. We specialize in pre-formulation development, formulation development, analytical development, Phase I, Phase II, small Phase III, and small commercial manufacturing.
Vesta Pharmaceuticals Inc.	A leading full-service pharmaceutical and nutraceutical contract manufacturing company, offering ANDA registration services, and regulatory consultation services.