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Phase 1 Clinical Services In North America
33 services found
by:Patheon Inc. based inDurham, NORTH CAROLINA (USA)
In late clinical phases, and as part of the establishment of your commercial supply, Patheon provides a complete validation package according to regulatory and cGMP ...
Manufactured by:BIOVECTRA based inCharlottetown, PRINCE EDWARD ISLAND (CANADA)
Our strong technical leaders drive projects throughout product life cycles—from early to commercial stages. They review methods and processes in-depth with our clients’ subject matter experts to map tailored development and commercialization paths, allowing us to improve the likelihood of success. Our nimble, phase-appropriate approach to pre-clinical and clinical material supply ...
by:Cytovance Biologics based inOklahoma City, OKLAHOMA (USA)
Cytovance® Biologics provides extensive mammalian and microbial pharmaceutical R&D service offerings that are both stand-alone and cGMP-enabling. Services include cell line development using Freedom® CHO-S® (Life Technologies), microbial strain development using GeneGPS Codon Optimization Technology (DNA2.0) and Cytovance® Biologics' Keystone Expression System™, ...
by:Patheon Inc. based inDurham, NORTH CAROLINA (USA)
With speed and efficiency, evaluate the properties of your biologic for a clear understanding of the path to Phase I clinical studies and beyond. Patheon gives you access to the full breadth of advanced analytical technologies and preformulation ...
Manufactured by:BioSensics LLC based inNewton, MASSACHUSETTS (USA)
BioSensics provides global operations services to optimize the delivery of BioSensics’ solutions throughout all phases of clinical studies and trials. Our experienced team delivers exemplary service and novel technology to improve data quality and save ...
Manufactured by:Sartorius AG based inGoettingen, GERMANY
A more seamless transition into the clinic. Complex biopharmaceuticals and advanced therapies can present challenges during preclinical development. When implementing an albumin-based solution, Albumedix can help avoid unnecessary complications in your preclinical testing by creating species-specific recombinant albumins to suit your preclinical models. Using our proprietary recombinant ...
by:Cytel based inWaltham, MASSACHUSETTS (USA)
Every year, sponsors hesitating to use a complex innovative clinical trial design routinely miss opportunities to optimize the speed, savings and probability of success of their clinical trials. Cytel's statistical consultants and data managers work in tandem with sponsors to ensure new medicines move forward with the right study ...
Manufactured by:RoosterBio, Inc. based inFrederick, MARYLAND (USA)
The path to IND approval for cell-based therapies can be challenging and time consuming with strict regulatory requirements. That is why RoosterBio provides Process Development Services to help you build clinical phase appropriate cGMP processes for your specific product needs. We have served many customers to streamline the path to clinical testing with our industry-leading hMSC bioprocess ...
Manufactured by:Forge Biologics, Inc. based inGrove City, OHIO (USA)
Plasmid DNA is an essential component of gene therapy development and the starting point of Forge’s idea-to-impact manufacturing services to accelerate gene therapy programs from preclinical through clinical and on to commercial manufacturing. Forge’s plasmid production with single-use systems incorporates seamlessly into our optimized AAV manufacturing process for increased ...
Manufactured by:Regis Technologies Inc. based inMorton Grove, ILLINOIS (USA)
Expedite your discovery-to-market timeline by partnering with Regis Technologies to produce your Active Pharmaceutical Ingredients (APIs) and intermediates. We are committed to advancing your projects from initial process development, scale-up development through final validation and commercial manufacturing. Partner with Regis to bring your regulatory starting material, pre-clinical, phase I-III ...
by:HingeClinica based inPrinceton, NEW JERSEY (USA)
Our Clinical Data Management team has solid experience in Phase I to Phase IV clinical data management services. We are committed to providing the highest data quality, integrity, and security for our clients in meeting 21 CFR part 11, GAMP 5 and HIPAA requirements. Using industry-leading electronic data capture (EDC) technologies. We provides end-to-end clinical data management support from eCRF ...
by:North American Science Associates Inc.(NAMSA ) based inNorthwood, OHIO (USA)
The clinical phase can be the most time consuming, least predictable, most expensive, and most important part of your development effort. So we work smart from the start, saving you time and preventing costly do-overs by optimizing strategies and tools to guide you through. Our clinical experience encompasses a broad range of technologies, therapies, and indications. With a tight focus on ...
Manufactured by:Ascendia Pharmaceuticals based inNorth Brunswick, NEW JERSEY (USA)
Ascendia works with discovery-stage pharmaceutical companies to provide lab-scale formulations suitable for pre-clinical testing. We conduct pre-formulation assessments, bioavailability modeling, and formulation approach comparisons. We provide trial formulations suitable for animal studies, toxicology studies, and cGMP clinical trial materials for Phase I studies. At Ascendia, our core business ...
by:Solvias AG based inKaiseraugst, SWITZERLAND
We provide rapid and comprehensive support for your early-phase drug development process, enabling you to establish 'critical mass' – in terms of personnel and know-how – in the chemical and analytical development of complex small-molecule ...
Manufactured by:HemoShear Therapeutics, Inc. based inCharlottesville, VIRGINIA (USA)
Using our powerful REVEAL-TxTM drug discovery platform, our scientists are identifying and validating promising approaches to develop novel treatments aiming to extend and improve the quality of life of patients with rare diseases. In our most advanced program, the company is conducting a phase 2 clinical trial of HST5040, an oral small molecule investigational drug for the treatment of patients ...
Manufactured by:Invicro, LLC based inNeedham, MASSACHUSETTS (USA)
Invicro’s medical image analysis team develops robust algorithms and pipelines to solve complex image science problems. Our team of over fifty medical image processing scientists, including more than twenty PhDs, is responsible for extracting scientific quantitative data in support of Invicro’s studies from discovery research through late-phase clinical trials. The medical image ...
Manufactured by:Pluristem Therapeutics Inc. based inHaifa, ISRAEL
Pluristem’s goal is to provide patients, physicians and healthcare systems around the globe with standardized, easy to use and highly effective PLX cell products that need no genetic or tissue matching prior to administration. We are active with many respectful regulatory agencies worldwide to advance our clinical programs towards marketing. Part of our clinical development strategy is to ...
by:Patheon Inc. based inDurham, NORTH CAROLINA (USA)
Broad experience and access to the latest technological capabilities are essential for today’s increasingly complex API development and manufacturing. By partnering with Thermo Fisher Scientific, you’ll work directly with scientists with deep chemistry knowledge and many years of experience in successfully supporting early and later phase clinical development programs. Our experts ...
Manufactured by:XyloCor Therapeutics based inWayne, PENNSYLVANIA (USA)
About the EXACT Trial for Refractory Angina Patients. The EXACT clinical trial is a Phase 1/2 multicenter, open-label, single arm, dose escalation trial. Approximately 12 subjects (N=3 per cohort) who have refractory angina will be enrolled into 4 ascending dose groups, followed by an expansion of the highest tolerated dose with 21 additional ...
Manufactured by:Entero Therapeutics, Inc. based inBoca Raton, FLORIDA (USA)
Latiglutenase, known as IMGX003, is an orally administered formulation comprising two recombinant proteases specifically targeting gluten proteins. It works by breaking down these proteins into smaller, non-reactive fragments, offering an adjunctive measure to a gluten-free diet for managing celiac disease. This autoimmune disorder affects the small intestine and is triggered by dietary gluten ...