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Light Sciences Oncology, Inc.

Logo Light Sciences Oncology, Inc.
  • Formulation development and drug delivery
  • Human Medicines
  • North America

Light Sciences Oncology (LSO) is developing Aptocine™ (talaporfin sodium) for solid tumors as well as other indications such as BPH. Aptocine is a water-soluble drug targeted by a small, single-use, disposable drug activator included with the drug. Aptocine is designed to provide tolerable, effective, and repeatable treatments for patients. LSO has completed treatment of patients in a Phase 3 trial of Aptocine in hepatocellular carcinoma (HCC), a Phase 3 trial for metastatic colorectal cancer (MCRC) and in Phase 1 and Phase 2 clinical trials in benign prostatic hyperplasia (BPH), or enlargement of the prostate. The company has positioned Aptocine to benefit an increasing number of patients with a strong portfolio of intellectual property, innovative applications in development, and an exceptionally capable and efficient team. More »

Pathology Diagnostics

Logo Pathology Diagnostics
  • Academic collaboration
  • Human Medicines
  • Europe, North America

Pathology Diagnostics Ltd. based in Cambridge, is a leading UK industry accredited research organisation providing tissue laboratory and diagnostic services to international pharmaceutical, biotechnology and companion diagnostics clients. We provided centralized integrated drug and biomarker testing on human and rodent tissues including IHC assay validation, digital whole slide scanning and fully automated quantitative image analysis enabling faster higher quality results at a fraction of the cost of traditional pathology approaches. We have a proven track record in early discovery & preclinical studies, clinical trials, biomarker and companion diagnostic R&D enabling you to make objective data driven decisions on your studies. We have published studies in cancer research including Clin Cancer Research, Science and Biomarkers in Medicine. Our team consists of on-site and remote medical and veterinary pathologists plus research scientists with several decades’ pathology and research experience. We hold full industry accreditation so that you may be assured that the results we generate are accurate consistent and reliable. Over the last few years we have performed over 75,000 biomarker analyses on patient samples from a wide variety of tumour and normal tissues and have evaluated over 130 biomarkers. These include identification of target and downstream proteins including cell surface receptors, signaling molecules, DNA repair, cell cycle, proliferation, apoptosis, immunomodulatory, angiogenesis, metabolic, and clinical markers.   We have introduced digital whole slide scanning and hosting using Aperio hardware technology to complement our automated image analysis platforms for preclinical and clinical studies. By investing in market-leading AperioTM whole slide scanning technology we can provide digital pathology services for healthcare and life sciences clients. The scanners allow conversion of microscope slides to high-resolution digital images as a starting point for computerised image analysis, telepathology (remote transmission and peer review by remote pathologists or collaboration between project scientists) quantitative biomarker and companion diagnostics evaluation.   Client portfolio: Pharmaceutical/biotech/CRO/academic cancer centres/companion diagnostics organisations Our portfolio includes top 10 global pharma/CRO organisations We also partner in EU academic/industry R&D collaborations More »

Advanced Technology Corporation (ATC Pharma)

Logo Advanced Technology Corporation (ATC Pharma)
  • Pre-clinical development and testing, pre-clinical CRO
  • Human Medicines
  • Europe

We are a CRO specialized in: bio-analysis of physiologically active substances and conducting preclinical studies (in vitro & in vivo) and conducting clinical trials (Early Phase). More »

Blue Stream Laboratories, Inc.

Logo Blue Stream Laboratories, Inc.
  • Formulation development and drug delivery
  • Human Medicines
  • North America

Founded to address the growing need for advanced, innovative biopharmaceutical product characterization and analytical testing, we are dedicated to finding solutions for our clients as they face common challenges. More »

Monogram Biosciences, Inc.

Logo Monogram Biosciences, Inc.
  • Analytical laboratory and testing services
  • Human Medicines
  • North America

We are a leader in developing and commercializing innovative products to help guide and improve the treatment of infectious diseases, cancer and other serious diseases. Our molecular diagnostics and testing services enable:  Pharmaceutical companies to develop new and improved antiviral therapeutics and vaccines as well as targeted cancer therapeutics more efficiently by providing enhanced patient selection and monitoring capabilities throughout the development process. More »

Certus International Inc.

Logo Certus International Inc.
  • GMP audit services
  • Human Medicines
  • North America

Certus International is an integrated Contract Research Organization and Core Imaging Services Company offering a full range of clinical trial management, consulting and imaging services. Certus, founded in 1995, is a company whose goal is to be accessible, reliable and transparent for its clients. We do this, in part, by being flexible, maintaining a flat organizational structure, having a real person answer the phone when you call and constantly improving customer service, no matter how good you think it is.  Evolving regulatory demands require well thought out, conscientious clinical trial designs, implemented by a dedicated and experienced clinical research team. The high-level vigilance necessary for your program requires detailed planning, oversight and execution; ensuring costs are managed and personnel motivated. Thorough planning, by forward-thinking statisticians, regulatory specialists and medical experts is invaluable to keeping your program running at the highest regulatory, ethical and clinical levels. We believe that early collaboration saves money, hassles, headaches and time, so we support clients as early as possible, helping with GMP planning and compliance.  Our QA and CMC early trial production involvement addresses future manufacturing, scale-up processes and clinical integration. We continue support through regulatory consulting and action-oriented experts, encouraging proactive communication with regulatory authorities and compliance through solid clinical trial planning and protocol development. Often companies, especially start-up organizations, will delay involving a CRO early in the clinical development stage in order to save money by doing much of the upfront work themselves. This approach frequently leads to lost time and extra costs later that could have been avoided with early guidance by an experienced team. The importance of properly powering your study is often not appreciated. Our experienced statisticians understand what is required and can often reduce costs and regulatory complications and frustrations, including additional trials. Our statisticians are sought after experts, established in the field, and have been requested to participate in internal FDA workshops.    We also strive to maintain an excellent working relationship with the FDA. Every clinical trial we partner on is customized per the sponsor’s requested needs and our suggestions based on the experience that 123 trials and over 15 years have given us.Not all clinical research programs require a year of planning, but many do. Connect with us as early as possible to allow adequate planning time. More »

CROSS Metrics

Logo CROSS Metrics
  • Clinical development and testing, clinical CRO
  • Human Medicines
  • Europe

CROss Alliance is a Swiss CRO group specialised in the performance and organisation of clinical trials . The first company of the group was founded in 1995 and at the moment is composed by three companies hiring 40 people: CROSS Research  owns a clinical phase I unit facility in Ticino (CH) and is specialised in the performance of clinical trials with healthy volunteers CROSS: CRO specialised in the coordination (from trial definition up to medical reporting)  and organisation of Phase I-III clinical trials in Europe CROSS Metrics: CRO specialised in Data Management and  Statistical analysis from phhase I to IV   CROss Alliance mission is to accompany the emerging biotech and the medium size pharmaceutical companies in the early development of new potential drugs. More »

Two Hats Regulatory Science GbR

Logo Two Hats Regulatory Science GbR
  • Academic collaboration
  • Human Medicines
  • Europe, Middle East

We suspect a good mix of, drug safety, business development, project management, quality assurance, pharmaceutical technology and probably a regulatory affairs hat also! We use the Two Hats principle, i.e. we try to help you wear the hat you need to concentrate on, whilst using our second hat of practical ethical regulatory science advice based on common sense. We are not a regulatory consultancy that claims to be able to do everything for everyone. We are a co-operative offering niche regulatory consultancy services for those companies and non-profit organisations that like a mix of creative solutions based on common (scientific) sense at a fair price. If we can not help you, we will inform you and where possible recommend someone who might be able to help, because our guiding business principles are based on integrity, transparency and simplicity. Two Hats Regulatory Science strives to: Provide clients with honest, pragmatic regulatory support based on scientific rationale and common sense, Stay patient focused, Be a small team of ethically motivated entrepreneurs, helping your business stay in business, Be open & transparent about costs: either €75 (Reg. Sci.) or €110/hour (Snr. Reg. Sci.). Manage our natural & human resources responsibly & effectively to reduce time, waste & costs, Mentoring & training of members of staff to help bring out the best in them, Create a fun, healthy and creative working environment. Remember we are only human and therefore not perfect! We aim not to accept projects: We are neither qualified to perform (hence strategic partners), Capable of completing to a high enough standard or do not have capacity for, We feel are unethical, More »

Focus Clinical Drug Development

Logo Focus Clinical Drug Development
  • Formulation development and drug delivery
  • Europe

The company is an independent drug development organisation with 120 employees, offering full-service Phase I to III clinical development packages or individual service modules. The headquarters are located in Neuss/Dusseldorf, Germany with affiliates in Heidelberg, Moscow, Belgrade. More »

Clinical Research Services Turku (CRST)

Logo Clinical Research Services Turku (CRST)
  • Pharmaceutical process development and validation
  • Human Medicines
  • Europe

We are a university-based contract research organization (CRO) that conducts clinical, preclinical and bioanalytical studies for the pharmaceutical industry and for other customers. We are run by experienced specialists with in-depth understanding of basic and clinical pharmacology and analytical chemistry, especially in therapeutic areas such as disorders of the central nervous system, metabolic diseases and cancer. More »

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