Regulatory Landscape and Compliance in Clinical Research

International Journal of Trend in Scientific Research and Development (IJTSRD)
Volume 7 Issue 4, July-August 2023 Available Online: www.ijtsrd.com e-ISSN: 2456 – 6470
@ IJTSRD | Unique Paper ID – IJTSRD59787 | Volume – 7 | Issue – 4 | Jul-Aug 2023 Page 693
Regulatory Landscape and Compliance in Clinical Research
Vaishnavi Sharad Patil, Pratik Prakash Katare
M. Pharmacy, Student at ClinoSol Research, Hyderabad, Telangana, India
How to cite this paper: Vaishnavi Sharad Patil |
Pratik Prakash Katare "Regulatory Landscape and
Compliance in Clinical Research" Published in
International Journal of Trend in Scientific
Research and Development (ijtsrd), ISSN: 2456-
6470, Volume-7 | Issue-4, August 2023, pp.693-
699, URL: www.ijtsrd.com/papers/ijtsrd59787.pdf
Copyright © 2023 by author (s) and
International Journal of Trend in Scientific
Research and Development Journal. This is
an Open Access article
distributed under the
terms of the Creative
Commons Attribution License (CC BY 4.0)
(http://creativecommons.org/licenses/by/4.0)
INTRODUCTION
Regulatory compliance in clinical research is of
paramount importance to ensure the safety, integrity,
and ethical conduct of studies involving human
participants. Clinical research aims to advance
medical knowledge, develop new treatments, and
improve patient outcomes. However, these goals can
only be achieved if the research is conducted with the
utmost adherence to established regulations and
ethical standards.
The significance of regulatory compliance can be
understood through several key points:
Patient Safety: Compliance with regulatory
requirements guarantees that research participants are
protected from potential harm. Rigorous protocols,
informed consent processes, and safety monitoring
mechanisms are in place to minimize risks to
participants' health and well-being.
Data Integrity: Adhering to regulatory guidelines
ensures the accuracy, reliability, and consistency of
collected data. Valid and trustworthy data are
essential for drawing meaningful conclusions and
making informed decisions about new treatments or
interventions.
Ethical Considerations: Regulatory compliance
ensures that research is conducted ethically,
respecting participants' autonomy, privacy, and rights.
Ethical principles are codified in guidelines such as
the Declaration of Helsinki and the Belmont Report,
guiding researchers in their interactions with
participants.
Credibility and Reproducibility: Regulatory
compliance enhances the credibility of research
findings. When studies are conducted according to
established standards, the scientific community can
have confidence in the validity and reproducibility of
the results.
Regulatory Approval: Regulatory agencies, such as
the FDA and EMA, review and approve clinical trial
protocols. Compliance with their requirements is
essential for obtaining the necessary approvals to
initiate and continue research activities.
Legal Consequences: Non-compliance with
regulations can lead to legal consequences for
researchers, sponsors, and institutions involved in
clinical research. Fines, penalties, and even criminal
charges can result from disregarding ethical and
regulatory standards.
Public Trust: Maintaining regulatory compliance
helps foster public trust in the research process and
the medical community as a whole. Transparency and
adherence to regulations are crucial for building and
maintaining a positive reputation.
Global Collaboration: With the increasing
globalization of clinical trials, adhering to
international regulatory standards facilitates
collaboration between researchers, institutions, and
regulatory bodies from different countries.
Innovation: Regulatory compliance encourages
innovation by ensuring that novel treatments and
interventions are thoroughly tested in a controlled and
ethical manner before being introduced to the broader
population.
Historical Evolution of Regulatory Framework
The historical evolution of the regulatory framework
in clinical research has been marked by a progression
from minimal oversight to increasingly stringent
guidelines aimed at protecting research participants,
ensuring data integrity, and upholding ethical
standards. Here is an overview of key milestones that
have shaped the current regulatory landscape:
Nuremberg Code (1947): In the aftermath of World
War II and the Nuremberg Trials, the Nuremberg
IJTSRD59787

International Journal of Trend in Scientific Research and Development @ www.ijtsrd.com eISSN: 2456-6470
Code established the first set of ethical principles for
human experimentation. It emphasized the
importance of voluntary informed consent,
minimizing risks, and the need for scientific
justification.
Declaration of Helsinki (1964): The World Medical
Association introduced the Declaration of Helsinki,
which outlined ethical principles for medical research
involving human participants. It emphasized the role
of independent ethics committees and the necessity of
informed consent. The Declaration has undergone
several revisions to adapt to changing research
practices and ethical considerations.
Thalidomide Tragedy (1960s): The Thalidomide
disaster, where a medication caused severe birth
defects, led to increased recognition of the need for
rigorous testing and regulatory oversight before drugs
are approved for public use. This event prompted
regulatory agencies to establish more stringent safety
evaluation procedures.
Kefauver-Harris Amendments (1962): In the United
States, the Kefauver-Harris Amendments were
enacted after the thalidomide tragedy. These
amendments required drug manufacturers to prove the
effectiveness and safety of new drugs before they
could be marketed. The amendments also established
the requirement for informed consent and reporting
adverse events.
Creation of the FDA (1938) and EMA (1995): The
United States established the Food and Drug
Administration (FDA) in 1938 to regulate food,
drugs, and cosmetics. The European Medicines
Agency (EMA) was established in 1995 to oversee
the evaluation and approval of medicinal products in
the European Union.
ICH Guidelines (1990s): The International
Conference on Harmonisation (ICH) brought together
regulatory authorities and the pharmaceutical industry
to develop guidelines that harmonize regulatory
requirements across different regions. The ICH
guidelines cover various aspects of drug
development, including safety, efficacy, and quality.
Good Clinical Practice (GCP) Guidelines (1996): The
International Council for Harmonisation (ICH)
introduced the Guideline for Good Clinical Practice
(GCP), outlining ethical and scientific standards for
designing, conducting, and reporting clinical trials.
GCP emphasizes participant protection, data integrity,
and regulatory compliance.
Strengthening Oversight (2000s): Regulatory bodies
worldwide continued to enhance oversight and
enforcement of clinical trials. The introduction of
electronic data capture (EDC) systems and increased
emphasis on data transparency contributed to
improving data quality and integrity.
ClinicalTrials.gov and EudraCT (2000s): The launch
of ClinicalTrials.gov in the U.S. and the European
Union Clinical Trials Register (EudraCT) in Europe
provided platforms for registering and reporting
clinical trials, promoting transparency and reducing
publication bias.
Emergence of Risk-Based Monitoring (RBM)
(2010s): Regulatory agencies and industry shifted
towards risk-based monitoring approaches, focusing
resources on critical data and processes to improve
participant safety and data quality while reducing
administrative burdens.
Key Regulatory Bodies and Their Roles
Several key regulatory bodies play pivotal roles in
overseeing and shaping the regulatory landscape of
clinical research to ensure ethical conduct, patient
safety, and data integrity. Here are some of the major
regulatory agencies and their roles:
Food and Drug Administration (FDA):
Location: United States
Role: The FDA is responsible for regulating food,
drugs, biologics, medical devices, and cosmetics in
the United States. It reviews and approves new drugs
and medical products, including clinical trial
protocols, to ensure their safety and effectiveness.
European Medicines Agency (EMA):
Location: European Union (EU)
Role: The EMA evaluates and supervises medicinal
products within the European Union. It assesses the
safety, efficacy, and quality of medicines, including
overseeing clinical trial applications and marketing
authorizations.
International Conference on Harmonisation (ICH):
Location: Global (Multiregional)
Role: ICH brings together regulatory authorities and
the pharmaceutical industry to develop harmonized
guidelines for drug development, including clinical
trials. These guidelines aim to streamline regulatory
requirements across regions and ensure consistent
standards.
World Health Organization (WHO):
Location: Global
Role: WHO provides global leadership in public
health, including guidance on ethical standards for
clinical research. It promotes the development of

international ethical guidelines and monitors
adherence to these principles.
Health Products Regulatory Authority (HPRA):
Location: Ireland
Role: HPRA oversees the regulation of medicines,
medical devices, and other healthcare products in
Ireland. It assesses clinical trial applications, monitors
trials' conduct, and ensures compliance with
regulations.
Pharmaceuticals and Medical Devices Agency
(PMDA):
Location: Japan
Role: PMDA evaluates and reviews new drugs,
medical devices, and regenerative medicine products
in Japan. It ensures that clinical trials follow ethical
guidelines and regulatory requirements.
Medicines and Healthcare products Regulatory
Agency (MHRA):
Location: United Kingdom
Role: MHRA regulates medicines, medical devices,
and blood components in the UK. It assesses clinical
trial applications and monitors trial conduct to ensure
compliance with ethical and regulatory standards.
Health Canada:
Location: Canada
Role: Health Canada regulates the safety, efficacy,
and quality of health products in Canada. It reviews
clinical trial applications and ensures that research
adheres to ethical principles and regulatory
requirements.
China National Medical Products Administration
(NMPA):
Location: China
Role: NMPA oversees the regulation of
pharmaceuticals and medical devices in China. It
reviews and approves clinical trial applications,
ensuring that trials follow ethical and regulatory
standards.
Therapeutic Goods Administration (TGA):
Location: Australia
Role: TGA regulates therapeutic goods, including
medicines and medical devices, in Australia. It
assesses clinical trial applications and monitors trials
to ensure compliance with regulations.
Regulatory Requirements for Clinical Trials
Regulatory requirements for clinical trials are
essential to ensure the safety, efficacy, and ethical
conduct of trials involving human participants. These
requirements vary by country and region, but they
generally encompass several key aspects. Keep in
mind that these regulations may have evolved since
my last knowledge update in September 2021.
Always consult the latest official sources and
regulatory bodies for the most up-to-date information.
Here are some common regulatory requirements for
clinical trials:
Informed Consent: Participants must provide
informed consent before participating in a clinical
trial. They need to be fully informed about the trial's
purpose, procedures, potential risks and benefits, and
their rights as participants.
Ethics Review: Clinical trials involving human
participants must be reviewed and approved by an
independent ethics committee or institutional review
board (IRB) before they can begin. The review
assesses the trial's scientific validity, ethical
considerations, and participant protection measures.
Trial Protocol: A detailed trial protocol outlining the
study's objectives, methodology, participant
inclusion/exclusion criteria, interventions,
assessments, and statistical analysis plan must be
developed and followed.
Good Clinical Practice (GCP): GCP guidelines ensure
the ethical and scientific quality of clinical trials,
including the design, conduct, recording, and
reporting of trials. Adherence to GCP guidelines is
crucial for data integrity and participant safety.
Investigational New Drug (IND) Application or
Investigational Device Exemption (IDE) Application:
Before initiating a clinical trial, sponsors must often
submit an IND or IDE application to regulatory
authorities (like the FDA in the United States or the
EMA in Europe) for approval to test new drugs or
medical devices in humans.
Safety Monitoring and Reporting: Sponsors are
responsible for monitoring the safety of participants
throughout the trial and promptly reporting any
adverse events or serious adverse events to regulatory
authorities and ethics committees.
Quality Control and Assurance: Trials should be
conducted with rigorous quality control and assurance
measures to ensure accurate data collection,
documentation, and adherence to the protocol.
Trial Registration: Many countries require the
registration of clinical trials in public databases (such
as ClinicalTrials.gov) before enrollment begins. This
promotes transparency and helps prevent publication
bias.

Data Handling and Recordkeeping: Accurate and
complete records of trial data, including source
documents, case report forms, and other relevant
documents, must be maintained.
Reporting and Publication: Sponsors are expected to
report trial results, regardless of outcome, in a timely
manner. Selective reporting of favorable outcomes
can lead to biased information.
Data Privacy and Protection: Participant data must be
handled confidentially and protected in accordance
with data privacy laws, such as the General Data
Protection Regulation (GDPR) in the European
Union.
Post-Trial Responsibilities: After the trial concludes,
sponsors must continue to monitor the long-term
safety and effectiveness of the intervention, and any
additional data should be reported as necessary.
Data Collection, Management, and Reporting
Data Collection:
Source Documents: Original documents, medical
records, and test results that provide evidence of trial-
related activities and observations.
Case Report Forms (CRFs): Structured forms used to
collect specific trial data, often in a standardized
format. Electronic CRFs (eCRFs) are increasingly
common.
Patient-Reported Outcomes (PROs): Data directly
reported by trial participants about their health status,
quality of life, and symptoms.
Clinical Assessments: Measurements, tests, and
observations conducted by healthcare professionals
according to the trial protocol.
Laboratory and Imaging Data: Results from medical
tests, such as blood tests and radiological imaging,
relevant to the trial's endpoints.
Data Management:
Data Entry and Verification: Data collected on CRFs
or eCRFs are entered into a secure database. Double
data entry and validation processes can help ensure
accuracy.
Data Validation: Automated checks and manual
reviews identify discrepancies, errors, or
inconsistencies in the data.
Data Monitoring: Ongoing review of data to ensure
protocol adherence, participant safety, and data
quality. Monitoring visits are conducted to verifydata
against source documents.
Query Management: Queries are generated when data
inconsistencies or missing information are identified.
Researchers and site staff address these queries to
rectify issues.
Audit Trails: Detailed records of data changes and
modifications, maintained for transparency and
accountability.
Data Security: Data is stored securely to prevent
unauthorized access or loss. Encryption and access
controls are employed.
Data Reporting:
Safety Reporting: Adverse events and serious adverse
events are reported according to regulatory
guidelines. A safety database tracks and analyzes
these events.
Interim Analysis: Periodic assessments of trial data
can be conducted to evaluate safety, efficacy, and the
potential need for early termination or protocol
modification.
Final Analysis: After trial completion, a
comprehensive analysis of collected data is performed
to draw conclusions about the intervention's effects.
Publication: Trial results are disseminated through
peer-reviewed journals, conference presentations, and
clinical trial registries, adhering to transparency
principles.
Data Sharing: Some trials require sharing of
anonymized data with other researchers for further
analysis or validation.
Regulatory Submissions: For drug and device trials,
data is compiled into a regulatory submission package
for review by health authorities.
Integrated Summary Reports: Summarize the trial's
results and data for regulatory submissions,
combining information from various sources.
Challenges and Considerations:
Data Integrity: Ensuring that data accurately
represents the trial's activities and outcomes,
minimizing errors and bias.
Electronic Data Capture (EDC): Transition from
paper-based data collection to electronic systems can
enhance efficiency and data quality.
Data Privacy: Adhering to data protection regulations
while maintaining participant confidentiality.
Cross-functional Collaboration: Effective
communication among researchers, data managers,
statisticians, and regulatory experts is crucial.
Protocol Adherence: Ensuring that data collected
aligns with the trial's predetermined methods and
endpoints.

Data Standards: Using standardized formats and
terminology to facilitate data integration and analysis.
Good Clinical Practice (GCP) Guidelines
Good Clinical Practice (GCP) guidelines are
internationally recognized ethical and scientific
standards that ensure the design, conduct, monitoring,
recording, and reporting of clinical trials involving
human participants are consistent, reliable, and
ethically sound. These guidelines provide a
framework for maintaining participant safety, data
integrity, and the credibility of trial results. GCP
guidelines are essential for ensuring the quality and
ethical conduct of clinical research.
Key elements and principles of Good Clinical
Practice (GCP) guidelines:
Ethical Considerations:
Trials should be conducted in accordance with the
ethical principles set forth in the Declaration of
Helsinki and other relevant ethical standards.
The rights, safety, and well-being of trial participants
must take precedence over scientific and societal
interests.
Trial Design and Documentation:
Trials should be scientifically rigorous, well-
designed, and based on a detailed protocol that
outlines the trial's objectives, methods, and statistical
considerations.
All trial information should be documented
accurately, comprehensively, and contemporaneously.
Informed Consent:
Participants must provide informed, voluntary, and
documented consent to participate in the trial.
Participants should be provided with understandable
and relevant information about the trial, including
potential risks and benefits.
Participant Rights and Safety:
Participants' rights, safety, and well-being must be
protected throughout the trial.
Medical decisions related to participants' treatment
and participation in the trial should prioritize their
health and safety.
Investigational Product (Drug/Device) Management:
Investigational products should be manufactured,
handled, and stored in compliance with regulatory
requirements and the trial protocol.
Adequate records of the product's use and disposition
should be maintained.
Data Collection and Documentation:
All trial data should be collected, recorded, and
reported accurately, transparently, and promptly.
Source documents and case report forms should
accurately reflect trial events and participant
outcomes.
Monitoring and Quality Assurance:
Trials should be monitored by qualified individuals to
ensure protocol compliance, participant safety, and
data integrity.
Quality assurance processes should be in place to
prevent errors and inconsistencies.
Safety Reporting and Adverse Event Management:
Adverse events and their management should be
reported and documented promptly and accurately.
Serious adverse events should be reported to
regulatory authorities, ethics committees, and
investigators in a timely manner.
Record Keeping and Archiving:
All trial-related essential documents should be
retained and archived appropriately, allowing
traceability and verification.
Role of Ethics Committees and Regulatory
Authorities:
Ethical review committees (IRBs) and regulatory
authorities play a crucial role in reviewing,
approving, and monitoring trials.
Clinical Trial Protocol and Amendments:
Changes to the trial protocol should be documented,
communicated, and approved by relevant parties.
GCP guidelines are issued by various organizations,
including the International Council for Harmonisation
(ICH) and regulatory bodies like the U.S. Food and
Drug Administration (FDA) and the European
Medicines Agency (EMA). Adherence to GCP is
mandatory for clinical trials involving investigational
drugs, devices, and biologics, and it is highly
recommended for other types of clinical research as
well.
Strategies for Ensuring Regulatory Compliance
Ensuring regulatory compliance in clinical trials is of
paramount importance to uphold participant safety,
data integrity, and the reliability of trial results. To
achieve this, a comprehensive understanding of the
applicable regulations within the specific region or
country is essential. Collaborating with experienced
regulatory affairs professionals or consultants can
provide valuable guidance in navigating the complex

regulatory landscape. Developing detailed and well-
structured trial protocols that encompass all aspects of
the study, from participant eligibility criteria to data
collection methods, is crucial for maintaining
consistency and adherence to regulatory standards.
Ethical considerations play a central role,
necessitating the approval of independent ethics
committees or institutional review boards (IRBs)
before trial initiation. This approval process ensures
the protection of participants' rights and adherence to
ethical guidelines. Establishing a robust informed
consent process, where participants are fully informed
about the trial's objectives, procedures, and potential
risks, is pivotal in ensuring their voluntary and well-
informed participation.
Qualified investigators and site staff are key
components in maintaining compliance. Proper
training and qualification ensure that the trial is
conducted in accordance with regulations and Good
Clinical Practice (GCP) guidelines, which are
internationally recognized standards for ethical
conduct and data integrity in clinical research.
Consistent documentation and record-keeping
practices are essential to capture trial-related activities
accurately, including participant interactions, adverse
events, and protocol deviations.
Active adherence to GCP guidelines guarantees the
scientific validity of the trial and its ethical conduct.
Regular monitoring visits and audits serve to confirm
that the trial is being executed as per the protocol,
regulations, and GCP standards. Establishing robust
data management processes guarantees the accuracy,
completeness, and reliability of data collected
throughout the trial.
Additionally, proactive safety reporting is essential,
ensuring that adverse events and serious adverse
events are reported promptly to regulatory authorities
and ethics committees. Transparent trial registration
and results reporting, regardless of the outcome,
contribute to the integrity of the research process.
Risk management plans help anticipate and mitigate
potential risks to participants and the study's integrity.
Maintaining open communication with regulatory
authorities and seeking their guidance and input as
needed can help ensure ongoing compliance. Lastly,
staying informed about evolving regulations and
guidelines is crucial to adapt practices and procedures
accordingly. By implementing these strategies,
clinical trial stakeholders can establish a robust
framework that ensures regulatory compliance,
participant safety, and the generation of reliable
scientific insights.
Future Trends in Regulatory Compliance
The landscape of regulatory compliance is on the
brink of transformation with the advent of various
future trends. The integration of technology is
becoming paramount, as digital solutions like
electronic data capture (EDC), electronic health
records (EHRs), and wearable devices are reshaping
data collection and monitoring in clinical trials. Real-
world evidence (RWE) is gaining prominence, as
regulators recognize the value of data from sources
like patient registries and wearable devices, providing
insights beyond traditional trial data.
The rise of decentralized clinical trials is altering trial
dynamics, leveraging telemedicine, remote
monitoring, and digital tools to enhance patient
convenience and diversify trial populations. Data
privacy and security have assumed greater
significance with stricter regulations such as GDPR,
mandating robust protection and responsible handling
of patient data. The integration of advanced analytics
and artificial intelligence (AI) is revolutionizing data
analysis, enabling real-time insights and proactive
safety monitoring.
Personalized medicine and biomarker-driven trials are
necessitating regulatory flexibility to accommodate
tailored treatments based on genetic and molecular
profiles. Efforts for global regulatory harmonization
are underway through initiatives like ICH, aiming to
align guidelines across regions and streamline
multinational trials. Patient engagement is gaining
traction, with regulatory agencies recognizing the
importance of patient input in trial design and
outcomes.
Real-time monitoring and auditing, facilitated by data
analytics and remote technologies, are poised to
enhance compliance oversight and issue
identification. Blockchain technology holds potential
to fortify data integrity, transparency, and traceability
across the trial lifecycle. These trends reflect a
shifting focus towards patient-centricity, data-driven
decision-making, and harnessing technology to
elevate regulatory compliance standards. Staying
attuned to these trends will be pivotal for
organizations navigating the evolving landscape of
regulatory compliance, especially within clinical
research and other regulated sectors.
Conclusion
The landscape of regulatory compliance is
continuously evolving, driven by a convergence of
technological advancements, patient-centered
approaches, and the need for data integrity. As
clinical trials become increasingly complex and
global, adherence to regulatory requirements remains
fundamental to safeguarding participant safety,

maintaining data accuracy, and upholding the
credibility of trial results.
The future holds a spectrum of transformative trends,
from digital transformation and real-world evidence
integration to decentralized trials and AI-powered
analytics. These trends not only enhance efficiency
and data quality but also offer opportunities for
greater patient engagement and personalized
treatment approaches.
Adapting to these trends necessitates proactive
collaboration with regulatory experts, continuous
training of trial personnel, and agile strategies to
ensure seamless compliance across changing
regulatory landscapes. By embracing these future
trends, stakeholders in the clinical research arena can
foster a culture of innovation while upholding the
ethical principles and standards that underpin
regulatory compliance. As the future unfolds, the
synergybetween technology, patient engagement, and
regulatory compliance promises to reshape the
landscape of clinical trials for the better, ultimately
benefiting patients, researchers, and the broader
healthcare ecosystem.
References
[1] World Health Organization. (2016). Good
Clinical Practice (GCP) Guidelines. Retrieved
from https://www.who.int/ethics/research/en/
[2] International Council for Harmonisation of
Technical Requirements for Pharmaceuticals
for Human Use. (1996). Guideline for Good
Clinical Practice E6 (R2). Retrieved from
https://database.ich.org/sites/default/files/E6_R
2_Addendum.pdf
[3] European Medicines Agency. (2021). Clinical
Trials Regulation. Retrieved from
https://www.ema.europa.eu/en/human-
regulatory/research-development/clinical-
trials/clinical-trials-regulation
[4] Food and Drug Administration. (2021).
Investigational New Drug (IND) Application.
Retrieved from
https://www.fda.gov/drugs/types-
applications/investigational-new-drug-ind-
application
[5] European Medicines Agency. (2017). Guideline
on Good Pharmacovigilance Practices (GVP)
Module VI – Management and Reporting of
Adverse Reactions to Medicinal Products.
Retrieved from
https://www.ema.europa.eu/en/documents/scien
tific-guideline/draft-guideline-good-
pharmacovigilance-practices-gvp-module-vi-
management-reporting-adverse-
reactions_en.pdf
[6] ClinicalTrials.gov. (2021). About Clinical
Studies. Retrieved from
https://clinicaltrials.gov/ct2/about-studies/learn
[7] European Medicines Agency. (2018).
Reflection paper on investigational medicinal
products (IMPs) and market authorisation
procedures. Retrieved from
https://www.ema.europa.eu/en/documents/scien
tific-guideline/reflection-paper-investigational-
medicinal-products-imps-market-authorisation-
procedures_en.pdf
[8] U.S. National Library of Medicine. (2020).
Informed Consent. Retrieved from
https://www.ncbi.nlm.nih.gov/books/NBK5089
56/
[9] World Medical Association. (2013).
Declaration of Helsinki - Ethical Principles for
Medical Research Involving Human Subjects.
Retrieved from https://www.wma.net/what-we-
do/medical-ethics/declaration-of-helsinki/
[10] Pharmaceutical Research and Manufacturers of
America. (2018). Principles on Conduct of
Clinical Trials and Communication of Clinical
Trial Results. Retrieved from
https://www.phrma.org/-
/media/Project/PhRMA/PhRMA-Org/PhRMA-
Org/PDF/P-R/PhRMA-Principles-on-Clinical-
Trial-Information-Communication.pdf

Regulatory Landscape and Compliance in Clinical Research

Recommended

Recommended

More Related Content

Similar to Regulatory Landscape and Compliance in Clinical Research

Similar to Regulatory Landscape and Compliance in Clinical Research (20)

More from ijtsrd

More from ijtsrd (20)

Recently uploaded

Recently uploaded (20)

Regulatory Landscape and Compliance in Clinical Research