Biologics Consulting Group

NCGS, Incorporated is a full-service international CRO managing clinical trials since 1984 in drug, biologic, device, diagnostics and consumer products. NCGS provides full-service or strategic sourcing needs focused on risk mitigation. Contingency planning is actively employed, not just planned for. NCGS is a WBENC certified diversity supplier.

NCGS has supported the development or expanded labeling of 78 approved products and has ZERO 483s.
NCGS clinical teams are first in class, highly- tenured professionals
- 10+ years’ experience; A team remains throughout the trial
- Turnover rates are discernibly different at less than 3% annually

CLINICAL TRIAL THERAPEUTIC FOCUS INCLUDES:
- Neuro-Psych (CNS)
- Infectious Diseases / Critical Care
- Oncology, hematology, transplant
- Trials in multiple other areas have been conducted

ROBUST DIVISION OF COMPLIANCE & RECRUITMENT SPECIALIST
- CAPA initiatives
- Due diligence auditing
- eTMF
- Subject recruitment
- Call Center 24/7
- Trial Rescue
- Safety, SAE narratives and SAE reconciliation

FULL SERVICES INCLUDE:
• Clinical Operations and Monitoring
• Fully Integrated e-Based iCloud Systems
- e-REMOTE: Risk-based monitoring
- eTMF: TMF Migration, Consolidation
- ePAY: Grants, Contracts, Payments
- eDM: EDC, IWRS
- ePRO:Patient Reported Outcomes
- eCLIN: CTMS
• Medical Monitoring & Clinical Safety
• Quality Assurance & Regulatory Compliance
• Global Strategic Sourcing
• Medical Writing
• Biostatistics

STATKING Clinical Services (SCS) is proud of its 30 year history of service to emerging pharmaceutical and medical device clients. Since the company's founding in 1989, the company has evolved from providing statistical consulting and data analysis services on a variety of household products to a full service Contract Research Organization (CRO) serving the pharmaceutical and medical device industries.

Today, the company employs a staff of product development specialists that are heavily involved in all phases of the Client's development program including protocol development, medical monitoring and clinical trial management. STATKING's highly experienced team of professionals has been instrumental in achieving regulatory approval for a number of new medical devices, drugs and biologics. At STATKING, our team is committed to providing services that meet or exceed all Federal Guidelines and Regulations for Good Clinical Practice.

Service Areas:
Protocol Development, Clinical Trial Management, Medical Monitoring, Clinical Study Monitoring, Medical Writing, Regulatory Submissions, Biostatistics, SAS Programming, Clinical Data Management and Safety Monitoring.

Therapeutic Areas:
Radiopharmaceuticals, Diagnostics, Oncology, CNS, Women's Health, GI, Orthopedic and Bone, Cardiac, Pain Management

Target Health (www.targethealth.com) is a full service CRO that champions the 'Paperless Clinical Trial'​ through our cutting edge eSource EDC software.

Our staff of clinical trial experts are ready to take on any type of trial: drugs, biologics or devices!

Areas of expertise include:
- Regulatory Affairs, comprising, but not limited to, IND (eCTD), IDE, NDA (eCTD), BLA (eCTD), PMA (eCopy) and 510(k) submissions
- Management of Clinical Trials
- Biostatistics, Data Management
- EDC utilizing our eSource software
- Project Management
- Medical Writing

Target Health has developed a full suite of cloud based eSource EDC software for managing all our clinical trials. Our software is in use at other CROs, numerous biopharmaceutical and medical device sponsors, as well as in trials at academic medical centers.

Our Target Health eSource EDC has range of capabilities:
- Full eSource EDC for paperless and paper-based clinical trials
- Target e*CTMS for managing trials of all sizes
- Target Document®, providing regulated document management system
- Target Encoder®, enabling coding of patient records with medical dictionaries
- Target SAE, for managing Serious Adverse Events, both during studies as well as after product launch.

Our software is built in a module fashion, and can be made available either standalone, together as a suite of software and with – or without – our CRO services.

To find out more, or to subscribe to our Newsletter, go to http://www.targethealth.com

Custom Biologics provide exceptional, high quality, customized assays to measure the functional properties of cellular and biotherapeutic drug candidates. We are a Health Canada audited, GMP-compliant, global service provider for functional testing of biotherapeutics, biosimilars and antibody drug conjugates.

For over 14 years our scientists have been designing and validating sophisticated bioanalytical assays, to characterize and measure the therapeutic potential of large and small molecule biotherapeutics.

Our work supports regulatory drug submission applications from biopharmaceutical companies throughout North America, Europe and Asia.

Great Science - It's at the heart of everything we do!

- Consulting company specializing in highly strategic drug-development advice and services for our partners in the pharmaceutical and healthcare industry
- Recognized insightful leaders who seek and create opportunities throughout the product life cycle to ensure each client’s asset is successfully transformed into a valuable therapy for patients
- Experienced team that successfully navigates across therapeutic areas, interacting with FDA divisions and building global development programs
- Collaborates with clients to provide embedded or virtual solutions by integrating seamlessly into product teams and advising senior management
- Also provides medical writing and submission services: Medical and scientific writing experts author a broad range of clinical and non-clinical documents and publications needed throughout a product’s development and for global regulatory submissions
- Operations and submissions experts have an approved FDA gateway and use validated eCTD software to perform client IND, NDA/BLA and pharmacovigilance to the FDA.

For a vast array of therapeutic categories, we provide:
- Strategic pharmaceutical analysis and brainstorming, including clinical and regulatory development
- Regulatory evaluations – expert data analysis, review and reporting
- Regulatory and medical due-diligence reviews, including evaluating data for licensing candidates
- Safety data analysis – drugs, devices and biologics
- Regulatory intelligence, including data assessment for “what-if” scenarios
- Clinical development planning and trial design.

Services Provided:
- Briefing packages:
from pre-IND to pre-NDA (drugs)
from pre-IDE to pre-PMA or 510k (devices)
- INTERACT Program, pre-BLA (biologics)
- IND preparation
- Preparation of regulatory applications in eCTD standard, including NDAs, 510ks, PMAs & BLAs
- Strategic documents for internal decision-making, including white papers
- New-product and marketing-materials evaluations
-Report writing for all clinical-trial phases