The document discusses the expectations that pharmaceutical companies have when outsourcing drug development work to Contract Research Organizations (CROs). It outlines that CROs are expected to expedite development through expertise, facilities, and by sharing responsibilities. However, there are also risks like poor data and regulatory violations. The key expectations are that CROs will deliver quality studies and data on time and on budget according to the contract, while complying with regulations. Success also depends on effective communication and a relationship based on mutual trust and respect between the sponsor and CRO.
2018 11-14 generating ideas on how to manage cro'seyalsron
Deconstructing challenges faced with working with CROs and effective processes to overcome them
Managing the process of relationship development with the right CRO to reduce unnecessary consumption of time
Unveiling mistakes and understanding the best way to work with CRO’s to strengthen relationships with your current and new vendors
Emphasizing the importance of coordination and communication and how that benefits your work load and organization of preclinical trials
Ovum Decision Matrix: Selecting an Outsourced Testing Service Provider 2014–15Cognizant
Cognizant has been recognized as “Market Leader” in Ovum Decision Matrix on Outsourced Testing Service Providers. According to the report, Cognizant stands out for how it articulates the implications of end-to-end responsibility and aligns them with organizational issues around testing services.
Given the stringent regulatory requirements in the health care industry, it is important for bio-pharmal companies to develop innovative Risk Evaluation and Mitigation Strategies (REMS) plans during the commercialization of certain products to ensure an acceptable risk-to-benefit ratio.
This benchmark study published by Best Practices, LLC examines how companies develop and execute successful Risk Evaluation and Mitigation Strategies (REMS) plans for newly-approved drugs in the U.S. market. This study can help bio-pharma companies in creating successful REMS programs.
Download Full Report: http://bit.ly/2aOt5Id
Vendor Alliance: Cultivating the Most Beneficial Vendor Relationshipseyalsron
My Presentation at the Arena International, Clinical Trial Supply NE, 2018-03-07. The full presentation could be found here: https://www.slideshare.net/eyalsron/cultivating-the-most-beneficial-vendor-relationships
Nearing the end of a long-term managed services agreement, DPS sought to evaluate its options and leverage a competitive sourcing process that defined a range of solution alternatives. The company’s over-arching objective was to drive transformational change that significantly increased service maturity and resulted in cost savings and other benefits, including improved speed to market, enhanced reliability and availability. DPS used an experienced and focused internal IT and Legal team, with support from ISG and external legal counsel, to execute the RFS methodology.
2018 11-14 generating ideas on how to manage cro'seyalsron
Deconstructing challenges faced with working with CROs and effective processes to overcome them
Managing the process of relationship development with the right CRO to reduce unnecessary consumption of time
Unveiling mistakes and understanding the best way to work with CRO’s to strengthen relationships with your current and new vendors
Emphasizing the importance of coordination and communication and how that benefits your work load and organization of preclinical trials
Ovum Decision Matrix: Selecting an Outsourced Testing Service Provider 2014–15Cognizant
Cognizant has been recognized as “Market Leader” in Ovum Decision Matrix on Outsourced Testing Service Providers. According to the report, Cognizant stands out for how it articulates the implications of end-to-end responsibility and aligns them with organizational issues around testing services.
Given the stringent regulatory requirements in the health care industry, it is important for bio-pharmal companies to develop innovative Risk Evaluation and Mitigation Strategies (REMS) plans during the commercialization of certain products to ensure an acceptable risk-to-benefit ratio.
This benchmark study published by Best Practices, LLC examines how companies develop and execute successful Risk Evaluation and Mitigation Strategies (REMS) plans for newly-approved drugs in the U.S. market. This study can help bio-pharma companies in creating successful REMS programs.
Download Full Report: http://bit.ly/2aOt5Id
Vendor Alliance: Cultivating the Most Beneficial Vendor Relationshipseyalsron
My Presentation at the Arena International, Clinical Trial Supply NE, 2018-03-07. The full presentation could be found here: https://www.slideshare.net/eyalsron/cultivating-the-most-beneficial-vendor-relationships
Nearing the end of a long-term managed services agreement, DPS sought to evaluate its options and leverage a competitive sourcing process that defined a range of solution alternatives. The company’s over-arching objective was to drive transformational change that significantly increased service maturity and resulted in cost savings and other benefits, including improved speed to market, enhanced reliability and availability. DPS used an experienced and focused internal IT and Legal team, with support from ISG and external legal counsel, to execute the RFS methodology.
Outsourcing in the Pharma Industry –
Experience, Expertise and Enthusiasm
Key success factors in fostering and
maintaining a long-term strategic partnerships
Insurers are upgrading their technology to support more complex
products, lower operating costs, and get closer to their customers.
But they can do more harm than good when they make changes
that alienate their independent agents. We’ve identified five steps
that can help insurers engage agents early and create a
transition plan that meets agents’ needs—converting these
important stakeholders into enthusiastic advocates.
This ISG white paper, co-authored by a senior IT leader at Boeing, discusses how an effective sourcing strategy requires a comprehensive and regimented process to address business needs, ensuring that decisions to renegotiate, renew or rebid contracts in a multi-sourced environment are made for the right reasons.
In spring 2016, PwC investigated the current state and
future direction of stress testing. We surveyed 55 insurers
operating in the US about their stress testing framework and
the specific stresses that they test. We also engaged in more
detailed dialogue with a number of insurers in the US and
globally, as well as with some North American insurance
regulators.
One of the fastest growing concerns on insurers’ enterprise risk agenda is model risk
management. From being a phrase that primarily actuaries and other modelers used, “model risk” has become a major focus of regulators and the subject of intense activity and debate at insurers. How model risk management has evolved from ad hoc efforts to its currentproactive stage is an interesting story. But more interesting still is
what we believe could be its next stage – generating measurable business value.
How engaged are the stakeholders in your clinical data management projects?
As you know that the engagement level of stakeholders play an important role for the success of the clinical trial. The attached article explains the importance and processes of managing stakeholders’ engagement in clinical data management. We hope that you find this useful. Connect with us to hear more from our experts in this area.
PwC Publication: TRID industry landscape 042216Tom Gere
PwC continues to provide client guidance to integrate TRID process and procedures. Happy to Discuss.
Tom Gere, Managing Director, PwC Thomas.gere@pwc.com
Outsourcing in the Pharma Industry –
Experience, Expertise and Enthusiasm
Key success factors in fostering and
maintaining a long-term strategic partnerships
Insurers are upgrading their technology to support more complex
products, lower operating costs, and get closer to their customers.
But they can do more harm than good when they make changes
that alienate their independent agents. We’ve identified five steps
that can help insurers engage agents early and create a
transition plan that meets agents’ needs—converting these
important stakeholders into enthusiastic advocates.
This ISG white paper, co-authored by a senior IT leader at Boeing, discusses how an effective sourcing strategy requires a comprehensive and regimented process to address business needs, ensuring that decisions to renegotiate, renew or rebid contracts in a multi-sourced environment are made for the right reasons.
In spring 2016, PwC investigated the current state and
future direction of stress testing. We surveyed 55 insurers
operating in the US about their stress testing framework and
the specific stresses that they test. We also engaged in more
detailed dialogue with a number of insurers in the US and
globally, as well as with some North American insurance
regulators.
One of the fastest growing concerns on insurers’ enterprise risk agenda is model risk
management. From being a phrase that primarily actuaries and other modelers used, “model risk” has become a major focus of regulators and the subject of intense activity and debate at insurers. How model risk management has evolved from ad hoc efforts to its currentproactive stage is an interesting story. But more interesting still is
what we believe could be its next stage – generating measurable business value.
How engaged are the stakeholders in your clinical data management projects?
As you know that the engagement level of stakeholders play an important role for the success of the clinical trial. The attached article explains the importance and processes of managing stakeholders’ engagement in clinical data management. We hope that you find this useful. Connect with us to hear more from our experts in this area.
PwC Publication: TRID industry landscape 042216Tom Gere
PwC continues to provide client guidance to integrate TRID process and procedures. Happy to Discuss.
Tom Gere, Managing Director, PwC Thomas.gere@pwc.com
International Pharmaceutical Industry: Feasibility Is Not (Anymore) A Plain S...KCR
Investigational Sites
The sole term ‘feasibility’ has multiple definitions in a clinical environment, leading to certain bias with all stakeholders involved, including pharma companies (sponsors) and all types of contract research organizations (CROs). The most common perception is related to a never-ending argument between pharma outsourcing departments and CRO commercial groups, with sponsors expecting CROs to run a (non-defined) feasibility study prior to proposal submission and CROs undertaking a series of schematic actions to create an impression of fulfilled expectation.
From complex coding requirements to strict patient referral rules, physicians are scrambling to avoid entanglements in a broad net of federal, state, and commercial payer requirements. Get ideas on how you can help protect your practice.
For more resources and information:
http://sites.mckesson.com/practiceconsulting/kc_coding.htm
Practices to ensure a successful technology transfer pradeepPradeep Jana
Implementing a technology transfer so the outcome is successful means paying attention to details at every stage of the transfer. For the transfer to be successful means the receiver company should be able to effectively use the technology again. To best go about a successful technology transfer, three main things have to be in alignment - Timelines & Deliverables, Procedure & Documentation and the Program Director
Customerlogo hereProject Name Project CharterCompanyOllieShoresna
Customer
logo here
Project Name: Project Charter
Company
logo here
Project Name:
Value Driven Project and Portfolio Management in the Pharmaceutical Industry
Project Charter
Project:
Value Driven Project and Portfolio Management in the Pharmaceutical Industry
Title:
Project Charter
Document number:
Version
0.1
Document status:
Final
Author:
Chellyn Jones
Responsible:
Date created:
14/08/2021
Protection class:
"For internal use only"
Document history
Version
Date
Author
Comment/Change
0.1
10/08/2021
Draft
14/08/2021
Final
Page
1Background/Project purpose or justification4
2Goals5
2.1Goals
2.2Scheduling goals/milestones
3Project product description6
4Delivery units7
4.1Delivery units/services
5Project success criteria8
6High-level risks9
7Key stakeholders10
8Assumptions, restrictions and external dependencies11
9Responsibility of the customer12
9.1Tasks
9.2Resources and staffing
10Project category13
11Project budget (overview)14
12Project startup15
13Project end16
13.1Signatures for release
Annex17
A.Glossary and abbreviations17
B.References, accompanying documents
1.
Background/Project Purpose or Justification
Pharmaceuticals' perspective has shifted as a result of the rising healthcare expenses that are currently affecting everyone, and pharmaceuticals are focusing on the generation of value in research and development. Value-driven portfolio management is a term that has long been associated with the financial sector but has recently gained popularity in the pharmaceutical industry. The notion of value-driven portfolio management focuses on connecting a company's strategic goals and objectives with resource allocation. A corporation can raise the value of pharmaceuticals while also lowering healthcare expenses by focusing on studying the risks and effects.
The project's purpose is to create a value-driven project for the pharmaceutical company by following a set of decision-making stages. The steps will include developing a targeted product profile, defining a timeframe, developing a budget that is consistent with the goal product profile, and ultimately developing a stage gate decision-making system.
2. Goals
This section addresses the goals of the project which indicate what the project intends to achieve and the milestones related to the goals established.
a. Goals
Goal
Description
Efficiency
Efficiency in the drug development process will mean that pharmaceuticals develop drugs through maximum utilization of the resources and ensuring that the waste products from the process are as minimal as possible.
Strategic alignment
The goal is to come up with projects that are aligned with financial and strategic goals of pharmaceuticals.
b. Scheduling Goals/Milestones
Schedule
Description
Phase 1
· Defining the scope and the budgets for the projects
· Developing the goals of the project.
· Evaluation of the potential risks
Phase 2
· Coming up with the key performance indicators
· Tracking per ...
Root cause Analysis (RCA) & Corrective and Preventive action (CAPA) in MRCT d...Bhaswat Chakraborty
This presentation describes Identification & differentiation of Protocol deviation & violation; Different methods of RCA & best suitable method for Multiregional Clinical Trial; CAPA management and CAPA application to other trial sites/CRO/SMO/ Country that is involved in same trial (Strategic Management and application of CAPA in MRCT)
This presentation gives effective solutions to outliers issue in bioequivalence trials. It described what would be acceptable to Regulatory agencies as well as some new approaches.
Equivalence approches for complex generics DIA 11 april 2019 Bhaswat Chakraborty
This is a workshop that i gave a few days ago on bioequivalence of complex generics like peptides, polymers, liposomes, colloids, ophthamic and topical produtcts.
Clinical trials that are needed for efficacy & safety evidence of Medical devices include feasibility (pilot) and Pivotal trials. An extended battery of preclinical trials are also needed for high risk devices.
Writing Science papers for for publication requires something more thatn creativity. Target journals, content organization, wrting style, elegance and referencing are equally important.
Multidisc review of NDAs and BLAs nipicon 2018 Dr. ChakrabortyBhaswat Chakraborty
NDAS and BLAs cannot be authoritatively reviewed these days until experts from different disciplines act together like a team. This presentation give some foundational points and an illustrative example in that regard.
Teaching by stories, anecdotes and historical facts sept 25 2018Bhaswat Chakraborty
Many difficult principles in science and humanities can be taught best by a story (of its discovery), by an anecdote or some historical facts about them.
Orientation and Adaptation for Post-Graduate Pharmacy ProgramsBhaswat Chakraborty
PG Pharmacy programs are more focused and professionally oriented than the undergraduate counterpart. Many soft skills are required along with the curricular competence for excellence at the PG level.
Scientific integrity calls for some basic originality. Plagiarism can destroy this original creativity and ideation. This presentation defines plagiarism (stealing from others' works) and some of the creative and systematic remedies.
Best Practices to Risk Based Data Integrity at Data Integrity Conference, Lon...Bhaswat Chakraborty
Data integrity can be implemented using several approaches. One of the most effective ways to implement DI is a risk based approach. The speaker elaborates this.
There are several dimensions in Pharmaceutical ethics -- Practice-, research- and community oriented. This presentation mainly deals with Clinical research oriented Ethics.
Young pharmaceutical scientists are and can get involved in all aspects of new drug discovery and development. They have to be appropriately qualified, trained and experienced though,
This presentation mainly deals with clinical development of biosimilar products. It also gives enough on non-clinical development so that the audience is well oriented.
High variability in PK can be a characteristic of certain drug products which require different from ordinary strategies and study designs for establishing bioequivalence.
High variability in PK can be a characteristic of certain drug products which require different from ordinary strategies and study designs for establishing bioequivalence.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Adv. biopharm. APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMSAkankshaAshtankar
MIP 201T & MPH 202T
ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS : UNIT 5
APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMS By - AKANKSHA ASHTANKAR
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...
What to expect from a CRO
1. Pharma Bio World August 2013 19
What to Expect from a CRO?
T
he title of this article begs another
question first. Why a do we
need a CRO (Contract Research
Organisation) for drug development, is
it essential? All pharmaceutical firms
including large MNCs require assistance
from CROs to expedite development of a
new drug or product to reduce costs and
in most cases to exploit CROs domain
expertise. CROs also provide the variety
and number of investigational sites with the
required training and qualifications that the
investigators ought to have.
Large biotech companies have such
complex and back and forth development
processes that it pre-requisites a CRO’s
support in product characterisation and
clinical testing at numerous stages. The
mid and small sized pharma companies
often do not have either a full-fledged
pre-clinical and clinical R&D or the generic
pipeline is too huge to be handled on
their own.
Thus in addition to provide expertise,
knowledge, equipments and facilities,
CROs can share the responsibilities (by
means of transferred authority) of drug
development with favourable timelines
and regulatory assistance. There are,
however, potential risks involved in all
outsourced works to CROs. Other than
losing direct control of the projects,
there are risks of poor or irrelevant data
generated, GXP violations, fraudulent
conduct of study and missed timelines.
Poor communication and relational
dissatisfaction could be other hassles
involved in outsourcing.
There are organisations
who have thoroughly and
quantitatively surveyed the
various areas of sponsor
expectations and whether
various CROs meet them
or not. Such surveys
provide very interesting
data that can help strategic
alliance and relationship
management between
sponsor companies and
CROs.1
The author of
this article has mainly
alluded to his experiential
qualitative data in writing
this article.
Twofold Relationship: Contract and Trust
Contracts define the legal and task
obligations of a CRO that is expected
by the sponsor. Thus, the practical and
commercial aspects of the relationship
between the sponsor and the CRO revolve
around what has been clearly embodied
and appended in the contract. Anything
that is not clearly written in the contract as
a deliverable by the CRO, will be treated
as a non responsibility of the latter in a
court of law. In fact one of the first things
to be expected from a CRO is a contract
that is clear and unambiguous in terms
of deliverable and has been written in
good faith.
The wholesome and long standing
relationship between these two entities,
however, cannot be entirely contractual
in nature. It is actually based on mutual
trust as any good relationship is. Trust in
and of what? The sponsor trusts that a
CRO will deliver quality studies and data
as mentioned in the contract within the
stipulated timeline. In return, the CRO trusts
that the sponsors will co-operate with all
necessary information, especially thorough
objectives and study protocols, make
milestone and final payments on time and
will not micro manage their projects while
being conducted by the CRO. Asherman
and Sagotsky have looked into the
potent role of trust in successful to “best”
sponsor-CRO relationships.2
Effective
communication plans should be evolved
such that detail processes for discussing
performance expectations, releasing
undue pressures and for escalation of
Dr Bhaswat S Chakraborty
Sr Vice President
Research & Development
Cadila Pharmaceuticals Ltd
“
“
Anything that is not clearly written in the
contract as a deliverable by the CRO, will be
treated as a non responsibility of the latter in
a court of law.
What to Expect from a CRO 19-21.indd 19What to Expect from a CRO 19-21.indd 19 8/21/2013 11:54:01 AM8/21/2013 11:54:01 AM
2. Pharma Bio World20 August 2013
Understanding the continuum is likely
to enhance the satisfaction at all levels.
Gains in delivery- and other critical
project-timelines constitute the most
discernible improvement in efficiency.
Improved timelines are best appreciated
when the budget and the scope of
the project have not been changed
disfavourably for the sponsor.
Improved efficiency over time with
monitoring of the CRO activities is a
positive sign of a successful sponsor-
CRO relationship. This also eliminates
micro-management of the CRO which
often poisons the relationship. Clarity
of all milestone activities and the scope
of data analysis should be understood
by the CRO such that all supervisory or
issues through the governance structure
are practised honestly.
Expect Value, Quality, Guidance and
Satisfaction
No matter how genuine the long term
relationship between a sponsor and a
CRO is, the latter is ethically and legally
bound to deliver value and quality in
conducting studies. Value in this context
is benchmarked science, following the
appropriate guidelines, GXP compliance
and timely delivery of projects. The
quality is the integrity and accuracy of the
data. The quality applies to both valid in-
process and analysed data, and its correct
interpretation in the reports prepared.
Reports must be in the regulatory
friendly formats (eg, CTD). The major
expectations and underlying needs met
provide the level of expectation that the
service receiving sponsor will experience
(Figure 1).
The Efficiency Continuum: Meeting
Timelines within Scope & Budget
Efficiency is a multi-significant term but is
mainly used for timeline, supervision and
process improvements. Efficiency is also
a continuum rather than being discrete,
arbitrary numbers on a scale.
review elements are exactly known by the
latter. This will reduce overseeing and
duplication dramatically.
Many CROs may specialise in process
improvement which may culminate into
generation of intellectual property rights.
The exact duration of relationship that
will lead to improved process efficiency is
rather difficult to predict as it depends on a
multitude of factors.
Regulatory Compliance
Except for a very small percentage of
the projects, all activities outsourced to
CROs are expected to follow applicable
regulatory requirements.
The good practices including GMP, GLP
and GCP must be in compliance with
following mutually agreed upon SOPs. QA
and QC must be vigilant and assuring to
the sponsor.
In addition to championing the compliance
with GXPs and other regulatory
requirements, all sponsors expect that the
CRO, that they have outsourced to, will
be able to quickly receive a local trial or
manufacturing license.
The CROs are also expected to know the
nuances of the local regulatory agencies
in terms of pre-requisite data and the time
required for receiving the approval for
trial conduct in details. The performance
standards of regulatory agencies are
different in various countries. Slower
approval times warrant a better planning
and preparation for the projects.
Figure 1: Schematic representation of the satisfaction gained by the sponsors when their needs are
met at different levels and cumulatively.
Table 1: Top 10 Expectations from a CRO
1. Competitive cost or clear cost advantage & adherence to budget
2. Timelines management within defined scope and budget for the project
3. Quality control and quality assurance
4. Regulatory compliance & strategic advice
5. Documentation in standard (international) formats
6. Low attrition rate of CRO personnel
7. Availability of adequate number of personnel in all pertinent areas
8. Involvement/intervention of senior management whenever necessary
9. Scientific and technical advice
10. Customer satisfaction assurance, metrics of satisfaction
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3. Pharma Bio World August 2013 21
a partner CRO. However, this is not the
general reality. The heart of the problem lies
in the lack of an effective implementation
of the partnership programme. Frequently,
the drive to save resources and costs
that led to strategic partnering in the
first place inhibits upfront investment
in the relationships. For example,
while it is acknowledged that frequent
communication, face to face meetings,
and training programs contribute to the
success of implementation of strategic
relationships, pressure to conserve costs
often prevent these from taking place.1
Conclusions
We have examined the nature and levels of
expectations that a sponsor pharmaceutical
or Biotech Company or any other
relevant entity may have from a contract
research organisation. The expectations
are based on mainly three parameters,
namely, scientifically accurate conduct
of the project, regulatory compliance and
meeting the success metrics in terms of
time, scope and budget. The experiential
data and published surveys point out that
the relationship between the CRO and a
sponsor must be based on honest faith,
transparent and well written contract
and mutual cooperation. The levels of
satisfaction gained by the sponsor will
depend not only on the selection of the
correct CRO but also on meeting mutual
goals, promises and milestones and on
excellence of communication.
References
1. The AVOCA Group (2010). 2010 Avoca
Report Executive Summary. http://www2.
theavocagroup.com/knowledge-center/
reports/2010-avoca-report-executive-summary
2. Asherman IG, Sagotsky B. (2009). Trust-
Based Influence and the Sponsor/CRO
Relationship. The Monitor (Association of
Clinical Research Professional Journal),
August 2009: 35-39.
3. Applied Clinical Trials Online (2013). 9th
Annual Avoca Industry Survey Results.
http://www.appliedclinicaltrialsonline.com/
appliedclinicaltrials/article/articleDetail.
jsp?id=807740
Contact: drb.chakraborty@cadilapharma.co.in
Learning Together: Mutual Respect
This article would be incomplete if
mutuality of responsibilities and roles is not
mentioned even though the theme of this
article is kind of unidirectional (sponsors
expectation of CRO). As mentioned
in the previous paragraph, successful
delivery of a project is not only the CROs’
responsibility it is also an accountability
of the sponsor. How so? Firstly, trust,
respect and learning together will bring the
members of the sponsor and the CRO team
together. Finally, in last two decades or so,
many refinements came through mutual
discussion and subsequent joint designing
of the projects by the aforementioned
two stakeholders.
Expectations that Lead to Success
Table 1 enlists the main expectations
that need to be met for successful CRO
projects leading to at least an appropriate
regulatory submission. At all stages of
a project or multiple projects, robust
systems for measuring performance
and relationship are very important.
Particularly important are metrics that
reflect status in an ongoing manner and
that are therefore actionable during the
course of a study.3
Successfully Met Expectations
In a survey conducted by Avoca group, it
was found that nearly half of the sponsors
had strategically entered into partnership
with CROs. The most common objectives
for launching these partnerships included
reduced costs, improved quality, improved
efficiency in use of internal staff, access
to operational expertise, and process
improvement. Among sponsor respondents
whose relationships spanned a period of
more than 3 years, there was considerable
variability in whether expectations in each of
these areas were met, and in the time it took.
For example, over half of the respondents
achieved cost savings in one year or less,
although, about a quarter reported never
achieving cost savings. Additionally, about
half of the sponsors achieved improved
quality within one year; however, nearly
20 per cent reported never achieving
this. Similarly, process and efficiency
improvements were attained by a little more
than one third of the respondents.3
Unmet Expectations
It has been observed that in poorly
performing strategic relationships, the
sponsor management is convinced that
they simply made the wrong choice of“
“
Successful delivery of a project is not only the
CROs’ responsibility it is also an accountability
of the sponsor.
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