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Clinical Phase Services In Usa
32 services found
Manufactured by:Nexelis based inSeattle, WASHINGTON (USA)
From Fit-for-Purpose Development to Qualified and Validated Clinical Assays. Nexelis, a Q² Solutions Company, is a leading partner in assay development and technology transfer, with scientific discipline, critical thinking, and agility. Fit-for-purpose assay development on a wide variety of platforms support your small molecule, large molecule, or vaccine program through all ...
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 ...
by:Cytovance Biologics based inOklahoma City, OKLAHOMA (USA)
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™, research cell bank production, process development, process optimization using statistical Design-of-Experiments (DoE), technology transfer, scaled-down model ...
Manufactured by:Regis Technologies Inc. based inMorton Grove, ILLINOIS (USA)
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 and commercial API to ...
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 ...
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, ...
Manufactured by:Nexelis based inSeattle, WASHINGTON (USA)
With an extensive track record developing, qualifying, validating, and transferring tests, our dedicated scientists support programs, from early development to clinical Phase ...
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. ...
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: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 ...
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) ...
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: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 ...
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 ...
Manufactured by:Invicro, LLC based inNeedham, MASSACHUSETTS (USA)
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 analysis team blends cutting edge image science with proven image engineering capabilities to ...
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)
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 offer you cutting edge technology from start to finish in multi-step chemical synthesis and from traditional to complex ...
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 subjects. ...
