Orbis Clinical is a specialized consulting firm that provides drug safety, risk management, regulatory, and quality assurance services to pharmaceutical and biotechnology companies. It has experienced consultants with decades of expertise in these areas. Orbis uses a flexible engagement model to quickly respond to clients' needs with individual specialists or broad-based teams.
Cell & Gene Therapy post-approval solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Andwin Scientific specializes in Clinical Supplies and Equipment product manufacturing, sourcing, procurement, storage and distribution as a supplier to global life science organizations and a distributor to direct end using companies (including sites). This makes Andwin Scientific the only company that offers true consolidation for clinical studies by facilitating the purchase of products from various suppliers in one transaction.
An overview of our Technology Accelerator business model. We describe a hybrid model leveraging minimally-dilutive funding and experienced pharmaceutical management to “de-risk” and drive projects to IND. Our area of expertise is prodrugs and infectious diseases (www.tsrlinc.com).
Cell & Gene Therapy post-approval solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Andwin Scientific specializes in Clinical Supplies and Equipment product manufacturing, sourcing, procurement, storage and distribution as a supplier to global life science organizations and a distributor to direct end using companies (including sites). This makes Andwin Scientific the only company that offers true consolidation for clinical studies by facilitating the purchase of products from various suppliers in one transaction.
An overview of our Technology Accelerator business model. We describe a hybrid model leveraging minimally-dilutive funding and experienced pharmaceutical management to “de-risk” and drive projects to IND. Our area of expertise is prodrugs and infectious diseases (www.tsrlinc.com).
Advance Your Program in China with Fully Integrated Clinical Development Solu...Covance
Meet your needs for greater efficiency, expanded capacity and customized support at the newly opened Covance Drug Development Center in Shanghai, China.
We are a Life Science staffing firm focused in the areas of Scientific, Clinical Research & Engineering for the US Biotech, Pharmaceutical, Medical Device and Diagnostic markets.
Generating and Communicating Evidence to Enhance Patient Care and Product Val...Covance
Covance has the expertise to help you overcome the unique challenges of late-phase clinical development. Find out how Covance supports new indications, value communication, adherence strategies, long-term safety and efficacy by reviewing our brochure.
As a leading staffing specialist with offices in the UK, Europe and North America our biggest USP is representing candidates of all levels across Research & Development, Operational Excellence & Performance, Manufacturing Quality, Compliance, Regulation, Data Management, Cost Optimisation and Innovation. We pride ourselves on being able to deliver to almost every requirement in your business, in any location you need it.
Take a look at our specialist areas covered across the USA.
Cliniminds- Skill Development Program in PharmacovigilanceCliniminds India
CLINIMINDS brings to you an intensive course covering all the aspects of case processing, specially designed for Pharmacovigilance professional.
Our training program involves:
1. Fresher training for Drug Safety Associate with Hands On experience on safety database
2. Training on Case Processing
3. Training on Aggregate Reporting with Hands On
experience in PSUR/ PBRER writing
4. Training on Signal Detection and Risk Management
5. Training on Regulatory Affairs on Audits
6. Training Medical and Scientific Content Writing
7. Customized Training on Pharmacovigilance (Designed exclusively for Corporate who need domain knowledge on specific area (s) of pharmacovigilance)
Overcome the unique challenges of late-phase product development and generate the right data to support your products' objective. Products in late-phase development have complex needs and demands. Programs at this phase support new indications, value communication, adherence strategies, safety and efficacy and more.
We are driven by a passionfor transforming products into brands and patients into survivors. Navicor is a 100% healthcare-focused, full-service agency that understands the unique aspects of the oncology marketplace. We have extensive oncology launch experience and have partnerships with large and small pharma and biotech companies.
Cell & Gene Therapy enterprise development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
An ever-evolving regulatory environment makes navigating gene therapy products through to clinic much more complicated than a traditional biologic. While manufacturing platforms and regulatory requirements for testing of antibodies has existed for decades, gene therapy platforms and their testing requirements are changing rapidly with the progression of products toward commercialization.
Clinical Research Organization Services | Contract Research Company - PepgraPEPGRA Healthcare
Pepgra is a global contract research organization and drug development services company. It provides various phases of clinical research trials services to pharmaceutical and biotechnology companies to help reduce the time and costs associated with drug development.
Contact Us:
Website : https://bit.ly/33Fwsye
Email us: sales.cro@pepgra.com
India: +91 9884350006
United Kingdom: +44- 74248 10299
SciPro is a people business. We specialise in sourcing, advising and introducing highly skilled life sciences candidates to our client partners across the globe, helping them to achieve their business goals. The art of recruitment isn't solely about filling jobs, it's about matching people with people and creating harmonious and successful working environments. As a leading staffing specialist with offices in the UK, Europe and North America our biggest USP is representing candidates of all levels across Research & Development, Operational Excellence & Performance, Manufacturing Quality, Compliance, Regulation, Data Management, Cost Optimisation and Innovation. We pride ourselves on being able to deliver to almost every requirement in your business, in any location you need it.
Pharmacovigilance Conference on Drug Safety to be held in Jan 2010 at Mumbai, Provenance Research and www.pharmacovigilance.co.in are proud media partners
Advance Your Program in China with Fully Integrated Clinical Development Solu...Covance
Meet your needs for greater efficiency, expanded capacity and customized support at the newly opened Covance Drug Development Center in Shanghai, China.
We are a Life Science staffing firm focused in the areas of Scientific, Clinical Research & Engineering for the US Biotech, Pharmaceutical, Medical Device and Diagnostic markets.
Generating and Communicating Evidence to Enhance Patient Care and Product Val...Covance
Covance has the expertise to help you overcome the unique challenges of late-phase clinical development. Find out how Covance supports new indications, value communication, adherence strategies, long-term safety and efficacy by reviewing our brochure.
As a leading staffing specialist with offices in the UK, Europe and North America our biggest USP is representing candidates of all levels across Research & Development, Operational Excellence & Performance, Manufacturing Quality, Compliance, Regulation, Data Management, Cost Optimisation and Innovation. We pride ourselves on being able to deliver to almost every requirement in your business, in any location you need it.
Take a look at our specialist areas covered across the USA.
Cliniminds- Skill Development Program in PharmacovigilanceCliniminds India
CLINIMINDS brings to you an intensive course covering all the aspects of case processing, specially designed for Pharmacovigilance professional.
Our training program involves:
1. Fresher training for Drug Safety Associate with Hands On experience on safety database
2. Training on Case Processing
3. Training on Aggregate Reporting with Hands On
experience in PSUR/ PBRER writing
4. Training on Signal Detection and Risk Management
5. Training on Regulatory Affairs on Audits
6. Training Medical and Scientific Content Writing
7. Customized Training on Pharmacovigilance (Designed exclusively for Corporate who need domain knowledge on specific area (s) of pharmacovigilance)
Overcome the unique challenges of late-phase product development and generate the right data to support your products' objective. Products in late-phase development have complex needs and demands. Programs at this phase support new indications, value communication, adherence strategies, safety and efficacy and more.
We are driven by a passionfor transforming products into brands and patients into survivors. Navicor is a 100% healthcare-focused, full-service agency that understands the unique aspects of the oncology marketplace. We have extensive oncology launch experience and have partnerships with large and small pharma and biotech companies.
Cell & Gene Therapy enterprise development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
An ever-evolving regulatory environment makes navigating gene therapy products through to clinic much more complicated than a traditional biologic. While manufacturing platforms and regulatory requirements for testing of antibodies has existed for decades, gene therapy platforms and their testing requirements are changing rapidly with the progression of products toward commercialization.
Clinical Research Organization Services | Contract Research Company - PepgraPEPGRA Healthcare
Pepgra is a global contract research organization and drug development services company. It provides various phases of clinical research trials services to pharmaceutical and biotechnology companies to help reduce the time and costs associated with drug development.
Contact Us:
Website : https://bit.ly/33Fwsye
Email us: sales.cro@pepgra.com
India: +91 9884350006
United Kingdom: +44- 74248 10299
SciPro is a people business. We specialise in sourcing, advising and introducing highly skilled life sciences candidates to our client partners across the globe, helping them to achieve their business goals. The art of recruitment isn't solely about filling jobs, it's about matching people with people and creating harmonious and successful working environments. As a leading staffing specialist with offices in the UK, Europe and North America our biggest USP is representing candidates of all levels across Research & Development, Operational Excellence & Performance, Manufacturing Quality, Compliance, Regulation, Data Management, Cost Optimisation and Innovation. We pride ourselves on being able to deliver to almost every requirement in your business, in any location you need it.
Pharmacovigilance Conference on Drug Safety to be held in Jan 2010 at Mumbai, Provenance Research and www.pharmacovigilance.co.in are proud media partners
1. Orbis Clinical is a specialized consulting firm focused solely on serving the
Drug Safety, Risk Management, Regulatory and Quality Assurance needs of our
clients.
DRUG SAFETY AT Orbis Clinical, we deliver highly qualified consultants to companies in the
pharmaceutical and biotechnology industries. Our flexible engagement model allows
RISK MANAGEMENT us to provide a wide range of tactical and strategic solutions to the challenges our
clients face.
REGULATORY AFFAIRS
QUALITY ASSURANCE THE professionals at Orbis Clinical have decades of experience as leaders in Drug
Safety, Risk Management, Regulatory Affairs, and Quality Assurance. Our niche
expertise has resulted in successful working relationships with the leading
STRATEGIC:
biopharmaceutical companies worldwide.
Resource/Solution
Development OUR MODEL
End-to-End Consulting
Engagements Whether the situation requires an individual specialist to address a sudden spike in
Assessment workload, or a broad-based team chartered to provide an end-to-end solution, Orbis
Regulatory Response Clinical's delivery model can quickly respond.
Drug Safety Physician
Practice
Consulting Engagements: Our experts possess decades of high-level,
strategic experience in focused areas of drug safety and regulatory. We only
TACTICAL: work with the top professionals in the industry.
Project Team Tailored Solutions: The right resources at the right time. Orbis engages in
Development strategic partnerships with leading biopharmaceutical companies to ensure
Staff Augmentation they will have access to the appropriate experts at the right time in their
clinical development lifecycle.
Orbis Clinical Advisory Services: Call on one of our experts. We have a strong network of
200 Unicorn Park Drive
4th Floor
consultants with a vast range of expertise across all areas of
Woburn, MA 01801 pharmacovigilance. In all likelihood, our professionals have overcome similar
challenges to those you currently face. We offer customized advisory services,
Elizabeth Davies feasibility assessments and creative solutions to our clients.
781-569-0607 x1912
Toll Free: Staff Augmentation: Our experienced recruiters have spent many years
1-866-879-1963 working with some of the best talent in the industry. Our bench may already
Fax: 781-569-0608 include those perfect candidates with niche skills that could properly address
Email:
ldavies@orbisclinical.com your current situation.
.
Providing the world’s leading biopharmaceutical organizations with drug safety, risk management,
regulatory affairs and quality assurance expertise essential in treating devastating disease.
2. Areas of Expertise
DRUG SAFETY
o AE/SAE Case Processing ORBIS Clinical has engaged with our Clients across their
o Individual case review Global Pharmacovigilance Departments. Whether providing
o Regulatory response
o Marketed product support
teams of experienced physicians or outsourcing entire projects
o Clinical trial support for remote work, our Physician Practice has provided the high
o Aggregate Data Review level expertise our Clients require.
o Signal Detection/Trending
o Epidemiology
RISK MANAGEMENT
TO mitigate your risk and ensure success throughout the drug
Risk Management Plans/MAPS lifecycle, Orbis Clinical has developed the knowledge and
REMS development and submission skill to respond to your risk management needs. Our experts
Gap analysis provide comprehensive consulting services to develop, refine,
Benefit risk assessments and implement your Risk Management plans, strategies, and
Health Economics and Outcomes
Research
guidelines.
REGULATORY AFFAIRS
o Global Labeling (clinical and post ORIBIS Clinical has the global regulatory expertise to meet
marketed) your analytical, strategic and operational needs. We align the
o Global Submissions (IND, IB, CSR, right capabilities with your projects to help you protect your
NDA, BLA, MAA, etc) drug development investment. Ultimately, we know that
o Regulatory Operations
accurate, timely submissions are key to Regulatory success.
o Chemistry, Manufacturing, and
Controls
o Medical/Regulatory Writing
QUALITY ASSURANCE
Auditing (Internal and External GxP) TO optimize your operations, Orbis Clinical has developed
SOP Development/Review
the expertise to assess, improve and support all of your quality
Process Improvement
Manufacturing Facilities needs. We work with you to develop and implement standards
QA/QC/Document Control and guidelines that promote quality assurance.
Clinical and Vendor sites
Document Review, Writing, and
Templates
th
Orbis Clinical ◦ 200 Unicorn Park, 4 Floor ◦ Woburn, MA 01801
1-866-879-1963 (toll free) ◦ 781-569-0607 (phone) ◦ 781-569-0608 (fax) ◦ info@orbisclinical.com