Orbis Clinical

Orbis Clinical, LLC - Company Overview

• Orbis Clinical is a staffing and consulting company providing contract, contract-to-permanent and direct-to-hire professionals focused on providing expertise in Drug Safety, Risk Management, Clinical Operations, Medical Affairs, Regulatory Affairs, and Quality Assurance Nationwide. We deliver highly qualified professionals to enable our clients to solve the key tactical and strategic challenges they face.

• With our corporate office located in the greater Boston area we have been servicing our clients nationwide since 2004. In 2009, Orbis Clinical was named to the Inc. 500 as one of the fastest growing companies.

• Our expertise has resulted in successful working relationships with the leading Pharmaceutical, Biotechnology, CRO’s and Medical Device companies worldwide. Our client portfolio includes a wide array of small, midsize, and large Fortune 100 companies.

• Orbis Clinical is focused on delivering flexible, client-driven solutions to meet the expectations, timelines, and deliverables of our clients.

• In addition to our currently engaged contractors and consultants, we maintain a virtual bench of top quality resources that can be employed as needed in a timely fashion.

Services and CapabilitiesDrug Safety/Risk Management: •AE/SAE Case Processing •PSURs, DSURs, SUSARs, PADERs, PBRERs, etc. •Case Review, Aggregate Data Review, Signaling and Trending •Label and Package Insert Development and Review •REMS, Risk Management Plans, Benefit-Risk Assessment

Clinical Operations: •Medical Monitoring, Clinical Monitoring/CRA’s, etc. •Project Management •Medical Writing

Regulatory Affairs: •Submissions: content development of all regulatory submissions •Operations: Indexing and cataloging , CTD, eCTD and SPL formatting •Medical writing and review of all regulatory documents (NDA,IND,BLA,CSR, etc.) •CMC: Strategy, Technical Operations, Submission Writing •Advertising Labeling and Promotions: development, guidance and review

Medical Affairs: •Medical Writing, Medical Communications •Medical Science Liaison •Physician level support •Product Launch Strategy •Formulate Publication Planning, etc.

Quality Assurance: •GXP and PV Auditing: Domestic and International

Drug Safety, Pharmacovigilance, Risk Management

Orbis Clinical works with dedicated consultants within Drug Safety, Pharmacovigilance and Risk Management to augment existing teams, outsource spikes in workload, or to bring an added level of subject matter expertise to your organization. Our consultants can provide the expertise to assist in the development and management of your clinical and post-marketed safety programs to ensure patient safety through efficient and effective processes.

STRATEGIC SAFETY CONSULTING• Gap analysis and process

improvement assessments• Strategic planning for the growth of

your Safety Departments

PHYSICIAN PRACTICE• Medical Review• Regulatory Response• Global Product Lifecycle

Management• REMS, Benefit Risk Assessments &

Risk Management Planning • Signal Detection & Aggregate Data

Review• Literature Reviews & Summaries

AE/SAE CASE PROCESSING• Call Center support, event data entry,

logging & tracking (MedDRA, WHO Drug), legacy case data entry, analysis of similar events, narrative writing & QC review.

• Completion of Aggregate Reports• Preparation of Drug Safety portions of

IND/BLA/NDA/Ad Hoc Reports.

Clinical Operations

At Orbis Clinical, we understand your industry is constantly changing as breakthroughs in technology and science lead to new pharmaceutical discoveries. Orbis Clinical supports the evolving clinical research industries by providing flexible staffing solutions to grow, develop, and manage your clinical trials. We assist with providing high quality, experienced professionals that understand and are passionate about achieving common goals.

Services Include:

• Strategic development and maintenance of clinical trials from protocol development through study close out.

• Operational support to handle small and large scale clinical trials.• Develop, implement, monitor, and support Standard Operating Procedures (SOPs) and work

processes.• Site selection, regulatory start-up, maintenance and close-out.• Deliver and maintain high quality data to support clinical trials. • Establish and maintain Trial Master Files in accordance with regulatory and ICH guidelines.

Regulatory AffairsOur Regulatory Affairs practice has dedicated resources to meet the mission critical and often timely challenges our clients face. Orbis Clinical has the global regulatory expertise to meet your analytical, strategic and operational needs. We align the right capabilities with your projects to help you protect your drug development investment. Ultimately, we know that accurate, timely submissions are key to regulatory success.

Services Include:• Regulatory Affairs Strategy• Global Submissions Planning, Writing and Management (IND,IB,CSR,NDA,BLA ,etc.)• Regulatory Operations - Strategy - eCTD/CTD Publishing - Document Management - Archiving• Global Labeling (all areas of clinical and post market)• Chemistry Manufacturing and Control (CMC) - Strategy - Technical Operations - Submission Writing• Medical/Regulatory Writing• Advertising and Promotions

Medical Affairs

Our Medical Affairs division has the disease experts to educate department members, see that consumer questions are addressed, provide input and expertise in the design and construction of all promotional materials and events, and provide informational services to health care providers in the community. Our professionals provide regulatory review to ensure all written documents are accurate and adhere to the guidelines mandated by the FDA, etc.

Services Include:

• Medical Writing• Medical Communication• Medical Information • Medical Science Liaison• Physician Support• Product Strategy• Publication Planning

Quality Assurance

Orbis Clinical has the Quality Assurance expertise to assist pharmaceutical and biotechnology firms with auditing and improvements relative to Good Clinical Practices/GCP, Good Laboratory Practices/GLP, and Good Manufacturing Practices/GMP.

Services Include:

Internal and external, domestic and international GXP auditing of:

• Manufacturing facilities• CRO’s, Investigators, Monitors, Suppliers, and Study Sites• Contract Laboratories, QC Laboratories, Central/Specialty/Analytical Laboratories• Licensing partners & Agreements• Mock FDA Pre-approval Inspection (PAI) Audits• Site Readiness Assurance Audits• Routine & For-cause Audits

The Orbis Customer Experience

Unparalleled Customer Engagement Process

Single Point of Contact Issue Resolution

24/7 Customer Service

Agile and Flexible Customer Support

Industry-Specific Experience & Expertise

Orbis Clinical Engagement Model

Our Approach: - Listen – Consult – Partner

We Listen to our clients to understand their issues and opportunities We Consult with our clients to discover the best solutions for them We Partner with our clients to introduce the right solution at the right time

Properly Structured:

Tactical or strategic, onsite or remote, time and materials or fixed price and deliverable: Orbis Clinical will develop an approach that best suits your business environment.

Sourcing Strategy

Scope of Delivery Capabilities

1. National Recruiting Center (Boston)

2. Full-time sourcing professionals dedicated to high volume needs

3. National Presence• 280 offices across the U.S.

Emphasis on Quality

Our engagement and delivery process results in quality the first time.

• Reduced on-boarding time from opening to start• Reduced Turnover• Reduced Cost• Increased Production• Increased candidate engagement/satisfaction