Center for Bioequivalence Studies and Clinical Research (CBSCR) is located in a purpose built, state of the art building spreading over 32,600 square feet. It includes a wide, sorted area for clinical activities equipped with all necessities, a modernized bioanalytical laboratory completely equipped with latest technological equipment for high throughput analysis of biological specimens, corporate office area, halls and auditorium for training and teaching purposes.
 
With consultations of experts from WHO (Switzerland) US, Canada, Germany, Geneva and Jordan as well as top professional in the field from local industry, CBSCR has emerged as an organization with enriched experience and expert top notch.
Through incessant research and innovation, CBSCR is dedicated to be an independent service provider of Bioavailability (BA) and Bioequivalence (BE) studies and Phase I, II, III clinical trials. The CBSCR is an approved clinical trial site from Drug Regulatory Authority of Pakistan (DRAP). The CBSCR is an approved CRO from DRAP to carry out clinical trials as per international guidelines. Similarly, CBSCR is also a licensed center from DRAP to carry out Bioequivalence Studies
 

 

 

Mission:

CBSCR is a committed “problem-solver” providing valid research and academic solutions to the society.

To add value to the field of drug research while keeping compliance to ethical, regulatory and scientific requirements.

 

Vision:

We aspire to be a top service provider catering to diversified needs of biopharmaceutical organizations and drug discovery and development  in the region.

Teamwork:

Teamwork creating talented, energetic team that works globally communicates extensively, is enthusiastic about and enjoys what they do.
 

Leadership:

Leadership provides positive change, supporting new creations providing a platform for learning professionally and to create value for stakeholders through sustained and profitable growth.
 

Customer Service:

Customer Service the long-term relationships with customers, focusing the attention to the needs of the customer and striving to exceed their expectations through a flexible, client solutions.
 

Integrity:

Integrity by acting on the continued assurance to ensure the business and scientific integrity; confidence-building measures through honest, ethical behavior; the acting with respect to the other; behaving, as responsible members of the local community.
 

Quality:

Developing a reputation for quality: the availability of services and information, which meets or exceeds quality standards demanded by customers, physicians, patients, and regulatory bodies.

R&D Department Drug Regulatory Authority, Government of Pakistan 
 

Center of Bioequivalence Studies and Clinical Research (CBSCR) is an approved center for conducting bioequivalence research studies by R&D Department of Drug Regulatory Authority (former Ministry of Health), Government of Pakistan.  The CBSCR is an approved clinical trial site from Drug Regulatory Authority of Pakistan (DRAP). The CBSCR is an approved CRO from DRAP to carry out clinical trials as per international guidelines.

Quality Management Systems ISO 9001:2008

Center of Bioequivalence Studies and Clinical Research (CBSCR) has successfully qualified Quality Management Systems ISO 9001:2008 requirements and has been certified for conducting analytical, clinical and pharmaceutical research.

ISO 17025:2005 General Requirements for the competence of testing and calibration laboratories

Center of Bioequivalence Studies and Clinical Research (CBSCR) is striving hard and plans to qualify ISO 17025:2005 Standards.Pre-assessment by the lead auditors of PNAC has already been conducted and full assessment will conduct soon.

CBSCR is highly committed to provide the superior quality research and technical services to our customers, in compliance with good practices i.e. GCP, GLP, GDP and all applicable requirements. Also to bring continual improvement in the effectiveness of the Quality Management system and services offered through review, innovations and training of staff while achieving organizational goals and targets

Center of Bioequivalence Studies and Clinical Research (CBSCR) is in strategic alliance with some research organizations of world fame. Some of such collaborations are listed as follows;
International Pharmaceutical Research Unit (IPRC)

IPRU is one of the leading CRO in Jordan working on local and international research projects. IPRC owns vast experience in BA & BE research with almost 1000 projects on various drug molecules. CBSCR is in strategic collaboration with IPRC for exchange in technical expertise and knowledge sharing.
 

BElab Jakarta, Indonesia:

BElab is a top notch CRO in Indonesia focused towards BA & BE Studies mainly. Team at BElab is dedicated to provide quality services, reliable, valid and timely results to its clients. CBSCR is in partnering relation with BElab for bioanalysis services.
 

Novagenix Drug Research and Development Center, Turkey:

Novagenix Drug Research and Development Center is the pioneer bioavailability and bioequivalence laboratory in Turkey. CBSCR and Novagenix Drug Research and Development Center have reached to an understanding for mutual cooperation in terms of sharing knowledge and providing technical assistance to each other.
 

Clinical Trials Laboratory Services:

Clinical Trials Laboratory Services (CTLS) is a London based organization providing laboratory services to pharmaceutical, biotechnological, clinical research and other related industries. CBSCR is in long term partnering relationship with CTLS in various research areas.

To meet up the demands of an ever exigent global marketplace, biopharmaceutical companies of all sizes are embracing strategic partnerships with clinical research organizations to create a cost-efficient blend of internal and external resources that helps them optimize their research requirements in product development process.

This novel approach allows them to reduce oversight costs and concentrate on their highest priorities. The benefits can include but not limited up to significant cost savings, accelerated pace of product development, better quality, and minimized risk.  To exploit these benefits, however, a biopharmaceutical company must choose the right partner – one with reasonable experience, proven processes, a prudent infrastructure, and range of biopharmaceutical services that meet their needs.

 

A unique combination of experties, resources and technology:

CBSCR is a top notch biopharmaceutical services provider offering a complete package with expertise, resources and technology within a single organization – a unique combination that provides assurance that your research needs will be met.  Some of the highlights of our unsurpassed qualifications include:

As a modernizer in the biopharmaceutical services industry, CBSCR continues to create new models of operating excellence and best practices to help our industry partners address emerging challenges with changes in regulatory requirements.  The proven benefits of CBSCR’s integrated approach include:
 

Cost savings – Reduced sponsor oversight, faster study start-up and closeout, and improved study management

Accelerated pace – Due to its infrastructure and resources CBSCR manages to support fast pace in completing research studies.

Risk mitigation – Improved data reliability, proven protocols, and greater focus on first-cycle approvals

Quality optimization – Standardized processes, improved training, and reduced data redundancy.

These benefits can help saving cost and reducing unnecessary exposure of human beings to drugs.

 

CBSCR - The right choice:

By selecting CBSCR as your strategic partner, your company can leverage our dedication, expertise and resources to accelerate the completion of key milestones in drug formulation development and registration, increase efficiency and reduce the cost of bringing generic products to local and export markets.

Regulatory and Data Management( RD) Department of CBSCR is well versed with national and international guidelines and requirements of clinical studies, especially of US-FDA, EMEA and WHO.
The R D Provide regulatory support for assigned clinical research projects by interacting with various departments/ teams to ensure filing of required regulatory documents on schedule as per regulatory forms.
 The Regulatory and Data Management dept. is focused on:

Protocol Writing & Its Approval

Regulatory and Data management department is expert in study protocol writing, processing them through ethical committees and getting approvals from IEC and Ministry of Health Pakistan, WHO, and other international regulatory body.

Investigational Drug Accountability

To maintain records of the delivered, dispensed, consumed investigational drugs at clinical site.

Study Report Compilation

The RD department is responsible for final Report compilation and report writing. The state-of-the-art computing technology and softwares are employed in all mathematical and statistical evaluations used in report generation.

Archiving

The RD department is also responsible for archiving of the study based documents and materials in compliance with all applicable regulatory guidelines.

Protocol and Regulatory Compliance

he RD department oversee all stages of the study for protocol adherence and regulatory compliance.

Archiving Facility

CBSCR have appropriately secure, environmentally-controlled space for the archiving of study related documents i.e. fire protected, water protected. It is under the supervision of regulatory department.
The following guidance, which reflects the requirements ICH Good Clinical Practice, is used to gauge the suitability of an archiving facility in Investigator site premises.

Record Keeping

All the records after the completion of the study including source documents retained for at least 15 years and will be destroyed keeping in consideration the protected health information and also the confidentiality of the organization and human subject in proper manner.

Confidentiality & Security

Access to the archive facility restricted and documented.

Environmental Conditions

Documentation stored in areas with minimal variation in temperature and humidity.

Prof. Dr. Atta-ur-Rahman has over 950 research publications in top international journals, 30 patents and 150 books written or edited, published and circulated internationally. He is also the Editor-in Chief of many European science journals. His research interests include synthesis of natural products, chemistry of bioactive secondary metabolites, development and use of modern NMR spectroscopic methods, search for new enzyme inhibitors and anti-oxidants as well as biotransformation of bioactive compounds.
 

Prof. Dr. M. Iqbal Choudhary has over 800 research publications in top international journals with cumulative impact factor of over 1500 and 6500 citations, 29 national and international patents and 35 books published and circulated internationally. He is also the Editor-in-Chief of 4 European science journals and book series. His current research interests include search for new and effective enzyme inhibitors, antioxidant and anti-angiogenic agents and anti-parasitic compounds.
 

Prof. Shah has over 380 research publications, authored three books, edited two books and seven chapters published by international publishers and circulated internationally. He has two US patent to his credit. His current research interests revolve around synthesis of artificial drug delivery systems based on the principles of synthetic supramolecular chemistry, the exploitation of the orientation of various rings like porphyrins, calix[n]arenes and cyclodextrins to form receptors; functionalization of metal-based nanoparticles.
 
Some of the awards and distinctions received by Prof. Muhammad Raza Shah include: Civil award (Tamgha-i-Imtiaz) by the President of the Islamic Republic of Pakistan Dr. M. Raziuddin Siddiqi Prize (2015) for Scientist Under 40 in the Field of Chemistry by Pakistan Academy of Sciences, Avicenna Science & Innovation Award (2015) by Brain Trust UK and Abdus Salam award in chemistry (2006) for young scientist. His authored book was declared best book in 2017 by HEC. He was also declared top scientists for the year 2019 by government of KPK. Prof. Shah is Fellow International Union of Pure and Applied Chemistry, Fellow the Chemical Society of Pakistan and Fellow Pakistan Academy of Sciences. He is Editor the Journal of the Chemical Society of Pakistan. He is also mentor of Pakistani International Chemistry Olympiad Team and Deputy Coordinator, of National Chemistry Talent Contest Program
 
Prof. Shah also won 10 research grants as a principal investigator including six million PKR grants from the Higher Education Commission of Pakistan along with a 10,000 USD grant sponsored by COMSTECH-ISESCO (Standing Committee on Scientific and Technological Cooperation - The Islamic World Educational, Scientific and Cultural Organization). In addition, he was awarded a grant worth of 8600 USD by IFS (International Foundation for Science); a grant worth of 21424$ sponsored by the Organization for the Prohibition of Chemical Weapons (OPCW).
Furthermore, Prof. Muhammad Raza Shah holds memberships in various institutes such as Member of Max-Planck Research School for Material Sciences and National Representative in Polymer Division, International Union of Pure and Applied Chemistry (IUPAC) 2008-2011. Moreover, he is a life member of Pakistan Chemical Society. He also has technical training in Scanning Tunneling Microscopy, Atomic Force Microscopy both in liquid and air.

CBSCR has a GCP compliant an independent clinical unit with all necessary equipments and instruments and housing capacity for large number of volunteers. It is under the supervision of trained and qualified team of experienced staff, clinical investigators and management.

Facilities for Volunteers:

Sufficient arrangement for screening and recruitment of study volunteers.

Pharmacy

A well equipped pharmacy for storing different investigational drugs at various temperature limits as per their requirements under a supervision of licensed pharmacist.

Safety Monitoring

Clinical facility has 24 hours safety monitoring procedure conducted by trained and qualified staff at CBSCR.

Intensive Care Unit

Clinical facility also includes a well equipped Intensive Care Unit (ICU) with all necessary equipments including Modernized ECG Machine, Multipara, Defibrillator, Resuscitator, suction machine, crash cart loaded with all emergency care medicines. A trained physician and nurse will take care of all emergencies arising during clinical research. For serious situations CBSCR is in contract with one of the biggest hospital in Karachi for providing emergency services.

Sample Processing Area

Samples collected from the subjects are processed and stored for analysis. Our processing facility has refrigerated centrifuges which enable us to process biological samples at different temperatures. For storage of samples we have Freezers providing liberty to store at -20 degree centigrade to -80 degree centigrade.

• Bioequivalence (BE) studies
• Bioavailability (BA) studies
• Clinical Pharmacokinetic (PK) studies
• Safety and tolerability studies
• First-in-human studies (Phase I)
• First-in-patient studies (Phase II)
• First-in-patient studies (Phase III)
• Drug-Drug interactions studies
• Bridging studies

• Method Development
• Method Validation
• Analysis of Biological Matrix
• Inter Laboratory Comparison

• Quantitative & Qualitative Testing
• Atomic Absorption 

 

Center for Bioequivalence Studies and Clinical Research (CBSCR) is a contract clinical research organization that mainly conducts clinical trials (i.e. Phase I, Phase II and Phase III) and bioavailability and bioequivalence studies. In bioavailability and bioequivalence studies two or more pharmaceutical products are compared in terms of rate and extent of absorption after administration in similar doses to study volunteers.

What is Clinical Research Volunteer?

Center for Bioequivalence Studies and Bioassay Research invites human volunteers for participation in clinical research studies. CBSCR provides opportunity for volunteers–local, national, and international–to participate in medical research studies (sometimes called trials). Study Volunteers provide researchers with important information for comparison with people who have specific illnesses. A large number of volunteers have participated in past in various studies conducted at CBSCR.
A clinical research volunteer is a person with no known significant health problems who participates in clinical research to test a new drug, device, or intervention. Research with volunteers is designed to develop new knowledge, not to provide direct benefit to study participants. Study volunteers have always played a vital role in medical research and progress of medical knowledge.

Facilities for volunteers at CBSCR

Housing facilities for volunteers are designed and developed keeping in consideration the comfort of subjects and compliance with regulatory & GCP-ICH standards as well. Our clinical facility comprises of:
 

a) Fully air-conditioned sleeping areas
b) Sorted lavatory and washroom section for subjects
c) Recreational and activity hall equipped LCD Televisions, indoor games with Wi-Fi internet access.
d) Full service and equipped Intensive Care Unit (ICU) with trained staff
e) Dining halls that offer comfortable seating for enjoying meals

 
What are the benefits of volunteering to take part in clinical research?

Study volunteers who take part in clinical research studies at CBSCR may:
 

a) Receive a thorough physical exam (in some studies)
b) Complete health screening including lab tests
c) Receive compensation for participating in the study
d) Playing great role in furthering medical knowledge
e) Have the satisfaction of helping someone suffering from a chronic, serious, or life-threatening illness
f) Provide important scientific information for developing new disease treatments

 
Will I be compensated?

Yes. CBSCR compensates volunteers for their time and, in some instances, for the inconvenience of a procedure. Compensation amount varies as per time and visits required for a particular study. Compensation is also calculated according to the level of inconvenience faced by subjects during the study.

Are there any risks?

The CBSCR staff will explain any risks, requirements (like age, health, weight, height, non smokers, non-addictive), restrictions (blood donation, eating and drinking), or possible side effects (hypersensitivity, headache, nausea, vomiting, skin irritation) before you agree to take part in any study. It is wise and important that you ask them any questions or voice any concerns before you make a decision about taking part.

What about confidentiality?

All information we receive is kept confidential to the extent possible by law. Bottom line, we will not release any information that identifies our volunteers to anyone else, unless we have permission to do so from the volunteer. The exception is that we are required to report information about child abuse and certain infectious diseases.
 
How are studies approved for volunteer participation?

Every clinical trial is approved and monitored by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) to make sure the risks are as low as possible and are worth any potential benefits. An IRB/IEC is an independent committee of scientists, physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation and international research standards, must get their research protocols reviewed by IRB/IEC that initially approves and periodically reviews the research progress.
In addition, physicians, scientists, and supporting staff rigorously screen all studies for safety, ethics, and need.

How can I volunteer?

To participate in the study as a volunteer you will contact us on our number +92-21-99261717), our related clinical staff member will register your name in volunteer data base record. You may also fill our online volunteer recruitment form provided at our official website for the consideration of your inclusion in our studies.
To participate in the in the study, we’ll ask you to provide some basic information and give us permission to share that information with the research team. If you are a potential match to a study’s requirements, the study team will contact you as soon as we will start the screening process.

How do I enroll?

You can contact us at +92-21-99261717 between 8:30am to 3:30pm (PST) or you will see news and updates at our website www.cbsbr.org for further details.  Person who wishes to be volunteer in our research must call himself/herself to register. Anyone who is between 18 to 50 years of age, and is study can be volunteer in our studies. You are also encouraged to enroll other people (family members, relatives and friends) as a volunteer after taking their consent for the same.

Who sponsors clinical trials?
             
Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies. Trials can take place in a variety of locations, such as hospitals, universities, doctors’ offices, or community clinics.

How can I find studies currently recruiting volunteers?

You can find information about research studies currently recruiting volunteers by visiting our website www.cbscr.org.

 
Phase I clinical trial bioavailability/bioequivalence (BE)/pharmacokinetic(PK) studies
The CBSCR has completed the following Phase I trial (i.e. Bioavailability (BA), Bioequivalence (BE) and Pharmacokinetic (PK) studies) on the Pharmaceutical products to support the national pharmaceutical industries.
 

 
  
Bioanalysis
A number of in house bio-analytical methods has been developed and validated by CBSCR which has been successfully applied in Bioequivalence/Pharmacokinetic studies :
 

 
Comparative Dissolution Profiling (CDP):

Principal Investigator/General Manager
Ph. No.: +92-21-99261717
UAN: +92 111 222 292, Ext: 233
Fax No.: +92 21 99261713-4, 34819018-9
Email: raza_shahm@yahoo.com, raza.shah@iccs.edu