Advanced Analytics Laboratories

While others are getting up to speed, DSP is getting results.

DSP Clinical is an award-winning, comprehensive CRO that delivers three distinct advantages — dedicated experts, straightforward pricing, and a perfect partnership. With a track record for getting drugs to market faster, DSP has managed more than 200 clinical trials in Phases I through IV across various therapeutic areas and has filed 24 regulatory submissions including NDAs, 510(k)s and PMAs.

Whether we are managing the entire study from start to finish or providing individual services, DSP’s global capabilities drive top-tier success for small to midsize pharmaceutical companies through unmatched experience, passionate leadership, aggressive strategies, and operational excellence.

We provide on-demand management and monitoring services that instantly scale to fit the size, complexity, and speed of your research study. Our extensive expertise covers a wide range of therapeutic areas that include reproductive endocrinology and infertility, urology, and gastrointestinal studies.

DSP takes a proactive, meticulous approach to customer studies and services. We understand customer needs and won’t settle for anything less than precision and accuracy for your clinical trial.

At DSP, we provide an effortless contracting process with fixed pricing, integrated budgeting, and no long-term contracts to simplify service delivery and minimize overhead. We identify and resolve potential study issues early and strategically allocate resources to ensure project completion on time and on budget. Our proven internal SOPs and QA metrics ensure that quality systems are in place and rigorously followed during every customer’s clinical study.

As a result of sustained company growth, we have ranked prominently on the Inc. 500/5000 list multiple times.

That’s a difference you can see. Distinctly DSP.

Founded in 2004, Pharmaron is a cutting-edge, fully integrated pharmaceutical R&D service platform supporting the life science industry. The company has invested in its people and facilities and established its comprehensive service offerings throughout the pharmaceutical R&D lifecycle. With operations in China, the US and the UK staffed by more than 11,000 employees, Pharmaron has an excellent track record in delivering end-to-end R&D solutions to its partners globally and enabling them to accelerate their novel drug discovery and development process.

Pharmaron is a contract research organization (CRO).

Services:
* Synthetic, medicinal and analytical chemistry services
* Biology services
* DMPK services
* Pharmacology services
* Drug safety assessment services
* Radiochemistry and isotopically labelled metabolism services
* Chemical & pharmaceutical development services
* Clinical development services

www.pharmaron.com

CRO - Contract Research Organization
Library Synthesis
CADD
Bioorganic Chemistry
Discovery Process Chemistry
Radiolabelled Chemical Synthesis
ChemInformatics
in vitro Biology
in vitro Screening
Structural Biology
in vivo Pharmacology
Animal Disease Models
ex vivo Pharmacology
Biomarkers
in vitro ADME
in vivo PK
PKPD
QA
Regulatory Affairs
Discovery Biologics
Process Chemistry
API Manufacturing
Material Science
Formulation Development
Drug Product Manufacturing
Toxicology
Safety Pharmacology
Genetic Toxicology
DART
Pathology
Immunotoxicity
Bioanalytical
14C / Carbon-14 Radiosynthesis
3H / Tritium Radiosynthesis
QWBA
mARG
Clinical AME
Mass Balance
Metabolite Profiling
Microdosing Phase 0
Absolute Bioavailability
DDI
First-in-Human (FIH)
Thorough QT(TQT)
Ethnobridging

Research Dynamics is a Clinical Research Organization (CRO) that provides high quality, flexible clinical trial services, GCP training, and consulting to the pharmaceutical, biotech, device industries as well as to investigators and academic medical centers. We use innovative technologies, experienced research professionals, and a commitment to clients through product development to approval.

As a full service CRO, we provide dedication, flexibility, value, and a unique depth of experience and expertise.
Complex trials or first trials in an emerging company require this depth of expertise and insight to ensure successful trial completion. Our strength is in our expericenced staff especially in clinical trial rescue studies where we can start work within 1-2 weeks. Our specialty is complex or difficult studies where our focused attention is needed.

As a focused CRO we concentrate on providing our clinical trial core competencies from site identification through trial conduct to final clean data collection. These activities include site monitoring, site management, project management, GCP auditing, regulatory document management and remote EDC monitoring.

As a full service CRO, we provide “best-in-class” experts for regulatory services, data management, statistics, pharmacovigilance, medical monitoring, etc. Our Clinical QA audit staff can conduct on-site clinical audits or internal audits such as report audits and documentation audits.

With the company’s training foundation, we continue to provide training in GCP and other research topics for any clinical research professional. We have written books on GCP for investigators, coordinators and monitors. Our templates for “SOPs for investigator sites” have been sold for over 15 yrs.

Our consulting services include assisting start-up companies with their clinical development plans, providing advice on clinical trials and process and system consulting.

TGA BioServices, an Absorption Systems'​ Company, is an FDA inspected contract research laboratory providing the Pharmaceutical, Biotechnology and Research communities a comprehensive range of laboratory services in support of research and clinical studies. We offer the client a complete package of customized testing systems utilized in preclinical through Phase IV studies, all in compliance with cGLP and cGMP requirements.

We specialize in the development and validation of immunoassay systems for the detection of target molecules, antibody responses and quantification in total compliance with QA and cGMP standards.

TGA BioServices also offers in vivo mouse studies for the optimization of vaccine immunization schedules, dosing, adjuvant screening, immunogenicity testing for the release and stability of bulk and finished clinical product, as well as complete antibody development programs. Furthermore, we offer Guinea pig dermal sensitization testing for the identification of contact allergens. All programs are supervised by an in-house Institutional Animal Care and Use Committee (IACUC), while the facility is USDA registered and AAALAC accredited.

Other services provided include FACScan cell labeling studies, tissue culture, endotoxin testing, basic R&D activities, sample storage, specimen collection kits with on-site training, data management, protocol generation (SOP), database/statistical analysis and consultation. TGA BioServices has the credentials your project is searching for.

BioAgilytix is a leading global contract research organization focused on supporting pharmaceutical and biotech partners in all phases of drug development. With laboratory locations in North Carolina’s Research Triangle Park; Cambridge, Massachusetts; San Diego, California and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of biologics across a number of industries and disease states.
BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, and GCP, as well as GMP quality control testing (i.e., product release testing, stability testing, etc.) BioAgilytix also offers diagnostic testing services at its CLIA-certified, CAP-accredited Boston laboratory.
BioAgilytix’s team of highly experienced scientific and QA professionals ensures high-quality science, data integrity and regulatory compliance through all phases of clinical development. BioAgilytix is a trusted partner to many top global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.