Osmovian International Limited

• Osmovian International Ltd., is a R&D outsourcing and vendor

management solutions provider, based in Leeds & Kent, UK and

Boston, MA.

• Osmovian, provides dedicated clinical outsourcing resource solutions

to biopharmaceutical, generic and MD&D companies, acting as our

customers outsourcing expert.

We have extensive experience of all stages

of the outsourcing process and can work with you at any point in

the cycle

Osmovian believes outsourcing relationships play a critical part in ensuring the

industry meets both its mission and obligation to deliver life-saving and life-

enhancing medicines to patients.

We offer a wide range of outsourcing support products and services to improve

the value and performance of outsourcing arrangements.

Outsourcing Directors

Outsourcing Consulting

Interim Outsourcing

Managers

Project Recovery

Service Provider Audits

Outsourcing Consortium

External & Interim Outsourcing Management Services

• Access to expert clinical outsourcing professionals for operational support

• initiating, contracting and overseeing critical clinical trials

• Improves supplier selection, performance and relationships

• Reduces overall project cost and risk profile

• Low fixed monthly fee

Interim Outsourcing Director

• Access to outsourcing director for on-going review of strategies and advising

senior management on outsourcing decisions

• Provision of category spend reviews and building business case to evaluate and

support decision making

• Ensures decisions are most appropriate for each individual organisation

• Ensures all expenditure is effectively managed

Outsourcing Effectiveness and Process Improvement

• Provision of expertise to perform a comprehensive review of all SOPs, tools,

techniques and staff capability in the area of outsourcing

• Provide a clear, action oriented improvement programme

• Ensures biopharma companies maximise their effectiveness, create value and

competitive advantages in this critical business area

• Establishing and continuously improving outsourcing infrastructure is vital to the

successful delivery of externalised clinical trials.

Osmovian International Limited

Our services reduce your overall outsourcing cost and risk profile, whilst

optimising supplier performance at a fraction of the cost of a permanent or

contract employee.

Biopharmaceutical companies of all sizes can benefit from the support of a

clinical outsourcing professional:

With internal resources at a premium, a full time dedicated outsourcing

professional can be difficult to approve.

This flat rate service provides frequent access to a dedicated outsourcing

manager who will work alongside you to enable your team to focus on the

highest value activities and delivery of the project

Deliver cost savings

Reduce the risks of

outsourcing

Assist with financial

compliance and control

Protect assets and liabilities

Issue avoidance or rapid

resolution

Enable technical staff to

focus on deliverables

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Operational Delivery

Minimum 12 Month Contract

Cost per month - £3.5k

Outsourcing Effort

Risk Profile

We work alongside your teams throughout the life of the study, dedicating

resource and effort during the times when the financial and delivery risks are

at their greatest; spreading the cost evenly across the year.

Assess client & study requirements

Scope setting

Proposal process & evaluation

Supplier evaluation & selection

Contract negotiation & writing

Vendor management

On-going contract oversight

Issue resolution

Financial reconciliation & study

close out

Activities

Osmovian International Limited

On-going review of current

spending practices

Identify & quantify savings

opportunities

Increased weight in contractual &

financial negotiations

Advise & support senior

management decision making

Validate current direction or

provide the case for change

Ensure outsourcing practices

compliment internal capabilities

Smaller biopharma companies may benefit from a frequent review from a

senior outsourcing director to provide input into outsourcing strategies and

oversee on-going activities.

Provides the appropriate stake holder support to embed good outsourcing

practice within your organisation at the highest level.

Ensures there is appropriate financial control and tracking on your

outsourcing spend.

Support and security for decisions involving significant organisation expense.

This service includes advising senior management, profiling spend categories,

and negotiating alongside executive decision makers to ensure that all

expenditure is effectively managed.

Osmovian International Limited

Establishing and continuously improving outsourcing infrastructure is vital to

the successful delivery of externalised clinical trials.

Ensures biopharma companies can create value and competitive advantages in

this critical business area.

NPD Outsourcing Maturity Levels

Reliable & Predictable

Performance

Ris

k /

Cost

/

Tim

eliness

Organisational

Preparedness

Organisational

Infrastructure

Organisational

processes, policies,

governance

Instilled

Outsourcing &

Institutionalised

Processes

Consistent & stable

outsourcing

relationships.

Innovation and

expertise benefits

from strategic

partners

Perf

orm

ance

Time

Spot to

Functional

Outsourcing

Maintenance &

Continuous

Improvement

Through the comprehensive review of all SOPs, tools, techniques and staff

capability, we provide a clear, action oriented improvement programme

to maximise the effectiveness of your outsourcing and procurement

practices.

Stage 1 Stage 2 Stage 3 Stage 4 Stage 5

• Business

Preparedness

• Costs & Spend

• Staffing

• Organisation

Impact

• RFIs

• RFPs

• Vendor

Selection

• Contract

Execution

• Update policy &

procedures

• Governance

structures

• Training

• KPIs

• Spend &

Savings

• Performance

Management

• Handover to

customer

management

Osmovian International Limited

The key operating principle of Osmovian is to avoid studies running into

difficulties through diligent oversight and relationship management.

No new product should fail to meet a development milestone due to poor

contracting practice or relationships.

Addressing issues as they arise or preparing for difficulties and working to avoid

them has massive benefits; saving money, time and effort in the long run.

Not always possible, however,

and relationships can

become strained for a

variety of reasons:

Supplier Dissolution

Budget Restrictions

Relationship Breakdown

Scope Changes

Performance Issues

Project Recovery

Osmovian can act as either as an independent party

to arbitrate between the Sponsor and Supplier, or as

the Sponsor’s advisor and negotiator to resolve

issues.

Our Aim:

• Bring studies back on track and budget whilst

rebuilding business-to-business relationships

Our approach:

• Get all parties focused on the problem;

• Avoid blame and fault finding;

• Recognise both parties have invested in the

relationship to date;

• Collaborate to find mutually beneficial solutions;

• Work together to a unified goal of delivering the

study or next milestone.

Focus on problem

Avoid blame

Recognise investment

Collaborate to find solutions

Work to unified goal

Managing Director: Mark Campbell is a seasoned outsourcing, change

management and negotiation professional, with a rich and diverse

experience in business and management consulting, gained in both

early stage and global world class life-science organizations.

Email: mark.campbell@osmovian.com Mobile: +44 (0)7775 438 676

Executive Director, R&D Outsourcing: Rob Aitchison is a highly

experienced Outsourcing professional. He has held senior roles within

Analytical Development and Clinical R&D Outsourcing; guiding and

setting new strategies of outsourcing and implementing them into

organizations.

Email: rob.aitchison@osmovian.com Mobile: +44 (0)7717 677 539

www.osmovian.com

+44 (0) 208 123 0402

Innovation House

Discovery Park

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom