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Center for Bioequivalence Studies and Clinical Research (CBSCR)
Center for Bioequivalence Studies and Clinical Research (CBSCR) was established in March 2006 in association with The World Health Organization (WHO), Ministry of Health (MoH) Pakistan, Islamic Development Bank (IDB) and Higher Education Commission of Pakistan (HEC). It is a component of Dr. Panjwani Center for Molecular Medicine and Drug Research, International Center for Chemical and Biological Sciences, University of Karachi, a world renowned research center in the region.
CBSCR is the Pakistan’s premier, most credible and recognized institution for bioequivalence/bioavailability and clinical studies.
CBSCR has successfully completed a number of Bioequivalence (BE)/ Pharmacokinetic (PK) and Phase I , II and III clinical Trials in compliance with national and international guidelines and regulatory requirements.
CBSCR is the Pakistan’s premier, most credible and recognized institution for bioequivalence/bioavailability and clinical studies.
CBSCR has successfully completed a number of Bioequivalence (BE)/ Pharmacokinetic (PK) and Phase I , II and III clinical Trials in compliance with national and international guidelines and regulatory requirements.
Center for Bioequivalence Studies and Clinical Research (CBSCR)
International Center for Chemical and Biological Sciences,
University of Karachi,
Karachi, Pakistan
Ph: (92-21) 37715064, (021)111-222-292 -351(Ext: 532)
Hours:
Monday to Saturday 8:30a.m. – 4:30 p.m.
About Us
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
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 and Vision
Values
| 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.
Accreditations
- DRUG REGULATORY AUTHORITY OF PAKISTAN (DRAP):
Center of Bioequivalence Studies and Clinical Research (CBSCR) is approved as an official site to conduct clinical trials and has received License from Drug Regulatory Authority of Pakistan (DRAP) , Government of Pakistan in different capacity including:
- to act as Bioavailability Bioequivalence (BABE) Center
- to act as Contract Research Organization (CRO)
- to act as Clinical Trial Site (CTS).
- Bioanalytical Laboratory
- QUALITY MANGEMENT SYSTEM ISO 9001; 2015
Center of Bioequivalence Studies and Clinical Research (CBSCR) have qualified Quality Management Systems ISO 9001:2015 requirements and has been certified for conducting analytical, clinical and pharmaceutical research under certified quality management systems
- ISO 17025:2017 GENERAL REQUIREMENTS FOR THE COMPETENCE OF TESTING AND CALIBRATION LABORATIES
Center of Bioequivalence Studies and Clinical Research (CBSCR) have achieved ISO 17025Accreditation since 2013 by the Pakistan National Accreditation Council (PNAC).
Quality Commitment
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
International Collaborations
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 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 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 (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.
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.
COLLABOTING SITES
 |
Why CBSCR?
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.
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:
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:
- Custom designed, state of the art building for conducting research projects which lie in the domain of BA, BE and Phase I
- Sophisticated equipments and procedures vital to successful results
- Scientific and medical expertise across all major therapeutic areas
- Advanced proprietary software applications for design and analysis of research studies
- Clinical and regulatory experts critically looking after the projects from these aspects
- Access to scientific databases
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.
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 Department
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.
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.
Faculty
Prof. Dr. M.Raza Shah
Director
International Center for Chemical and Biological Sciences (ICCBS)
(H. E. J. Research Institute of Chemistry and
Dr. Panjwani Center for Molecular Medicine and Drug Research)
University of Karachi, Karachi-75270, Pakistan.
Principal Investigator/General Manager
Ph.D.(Professor)
E-mail:raza.shah@iccs.edu
E-mail:raza_shahm@yahoo.com
Telephone: 111-222-292 Ext: 233
Office: TWC-Room #203/CBSBR-Room #420
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.
Facility & Infrastructure
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. A modern infrastructure, furnished with a full scale clinical research facility with more than 100 beds hospital, state-of-the-art Bioanalytical laboratory, Archival facility, Pharmacy, and miscellaneous section along with corporate offices under the same roof. The center is well equipped with all high tech facilities and trained manpower, needed to carry out clinical studies, according to the international standards.
The facility mainly comprises of:
The facility mainly comprises of:
- Clinical Unit:
Are designed in compliance with regulatory & ICH- GCP standards. CBSCR clinical facility includes:
- Fully air-conditioned wards with more than 100 beds capacity
- Sorted lavatory and washroom section for participants
- Recreational and activity hall equipped with LCD Televisions, indoor games with Wi-Fi internet access.
- Fully equipped Intensive Care Unit (ICU) with trained staff
- Dining halls that offer comfortable seating for enjoying meals
- Sample Storage area with four -80oC and two -20oC freezers,
- Pharmacy area for the management of study medicines.
- Bioanalytical Unit:
Modernized Bioanalytical laboratory completely equipped with latest technological equipment for high throughput analysis of biological specimens including.
- High Performance Liquid Chromatography (HPLC)
- Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)
- In vitro Testing instrument to perform pharmaceutical quality testing and standardization:
- UV-Spectrophotometer
- FTIR
- Polarimeter
- Real time PCR
- Dissolution Unit
- Disintegration Unit
- Colony Counter & Microscope
- Biological safety cabinet
- auto clave
- Hardness Tester'
- Archive Area:
For the archival of study documents, study medicines and study biological samples, CBSCR has its own dedicated facilities.
CLINICAL FACILITY:
Fully furnished and air conditioned wards with hundred plus capacity |
Comfortable, relaxed and hygenic environment as per ICH-GCP
guidlline |
Dining hall facility |
Storage area with four -80oC and -20oC freezers
|
Medical officer room |
Emergency Care Unit (ECU)
with all necessary equipment. |
Recreational and Activity Hall equipped with LCD television, indoor games and
Wi-Fi services |
Intensive Care Unit (ICU) with all necessities (ECG Machine, Defibrillator, Resuscitator, Electric suction machine etc.)
|
BIOANALYTICAL FACILITY:
 Drug Extraction Lab
|
 LC-MS/MS
|
 HPLC
|
 GC-MS/MS
|
 Dissolution Testing
|
 Atomic Absorption Spectrophotometer |
 Disintegration Testing
|
 FTIR
|
 Power Backup UPS System |
 Incineration Facility |
 All-time Available Ambulance |
 Access control Entrance |
 Safety System |
 Fire Squad and Fire Vehicle |
 Dedicated Archive Area |
Services Portfolio
Services Portfolio
Through incessant research and commitment, CBSCR is dedicated to be an independent service provider of clinical trials including Pre clinical studies. For the smooth & timely execution of the trials, CBSCR has its own healthy participant’s pool. The services CBSCR offers to national and international pharmaceutical and other industries are:
Through incessant research and commitment, CBSCR is dedicated to be an independent service provider of clinical trials including Pre clinical studies. For the smooth & timely execution of the trials, CBSCR has its own healthy participant’s pool. The services CBSCR offers to national and international pharmaceutical and other industries are:
Pre-Clinical Studies
|
Pharmacovigilance
|
Clinical Studies
|
Medical Writing and Solutions
|
Bio Analytical Services
|
In-Vitro Testing
|
Regulatory Services
|
Volunteers
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?
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.
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
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
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.
Achievements
EXPERIENCE
1. Bioequivalence/Pharmacokinetic Studies:
CBSCR conducted Phase I clinical trial including Bioavailability (BA), Bioequivalence (BE) and Pharmacokinetic (PK) studies on the Pharmaceutical products to provide Health care solutions in terms of quality medicines.
| BA/BE/PK CLINICAL TRIALS CONDUCTED BY CBSCR | |||||||
| S. No | Drug | Study Type | S. No | Drug | Study Type | ||
|
|
Mefenamic Acid | Pharmacokinetic |
|
.Atorvastatin | Bioequivalence | ||
|
|
Atenolol | Bioequivalence |
|
Candesartan Cilexetil | Bioequivalence | ||
|
|
Peginterferon | Bioequivalence |
|
Gabapentin | Bioequivalence | ||
|
|
Ethionamide | Bioequivalence |
|
Candesartan + HCT | Bioequivalence | ||
|
|
Naloxone | Pharmacokinetic |
|
Losartan Potassium | Bioequivalence | ||
|
|
Clarithromycin Tab. | Bioequivalence |
|
Diclofenac Sodium | Bioequivalence | ||
|
|
Levofloxacin | Bioequivalence |
|
Omeprazole | Bioequivalence | ||
|
|
Amlodopin | Bioequivalence |
|
Spironolactone | Bioequivalence | ||
|
|
Clarithromycin Susp. | Bioequivalence |
|
Ciprofloxacin | Bioequivalence | ||
|
|
Clopidogrel | Bioequivalence |
|
Dexlansoprazole | Pharmacokinetic | ||
|
|
Moxifloxacin | Bioequivalence |
|
Ticagrelor | Bioequivalence | ||
|
|
Lamotrigine | Bioequivalence |
|
Dexlansoprazole | Bioequivalence | ||
|
|
Rivaroxaban | Bioequivalence |
|
Rosuvastatin | Bioequivalence | ||
|
|
Salsalate | Pharmacokinetic |
|
Sacubitril/ Valsartan | Bioequivalence | ||
2. Clinical Trials:
Traditional Chinese Medicine (TCM), as a major component of complementary and alternative medicine remedies, has attracted increasing attention worldwide because of its satisfactory clinical efficacy. CBSCR has completed following trials as per the international guidelines and standards:
| CLINICAL TRIALS CONDUCTED BY CBSCR | ||||
| S. # | Drug | Phase | Treatment | No of participants |
| 1. | Yinhuang Qingfei Capsule (Traditional Chinese Medicine) | II | Chronic Simple Bronchitis | 212 |
| 2. | Jinhua Qinggan Granules (Traditional Chinese Medicine) |
II | COVID-19 infection | 300 |
| 3. | SARS-CoV-2 vaccine (Inactivated Vaccine) |
I | Safety and Immunogenicity Evaluation | 112 |
| 4. | Houtou Jianweiling Tablet (Traditional Chinese Medicine) |
II | Chronic Non-Atrophic Gastritis | 240 |
| 5. | Fuke Qianjin Capsule (Traditional Chinese Medicine) |
II | Pelvic Inflammatory Diseases | 198 |
| 6. | Jinhua Qinggan Granules (Traditional Chinese Medicine) |
III | Acute Upper Respiratory Tract Infection | 273 |
3. Bioanalysis:
A comprehensive analytical testing laboratory provides deep scientific expertise, advanced instrumentation, and strict regulatory compliance to evaluate and quantify drugs. Utilizing LC-MS/MS, and HPLC CBSCR has developed specific methods to separate and quantify drugs:
A comprehensive analytical testing laboratory provides deep scientific expertise, advanced instrumentation, and strict regulatory compliance to evaluate and quantify drugs. Utilizing LC-MS/MS, and HPLC CBSCR has developed specific methods to separate and quantify drugs:
| IN HOUSE DEVELOPED AND VALIDATED BIOANALYTICAL METHODS | |||||
| S. # | Compound | Methodology | S. # | Compound | Methodology |
|
|
Amlodopin | HPLC |
|
Losartan Potassium | HPLC |
|
|
Atenolol | HPLC |
|
Mefenamic acid | HPLC |
|
|
Atorvastatin | LC-MS/MS |
|
Moxifloxacin | HPLC |
|
|
Azithromycin | LC-MS/MS |
|
Naloxone HCl | LC-MS/MS |
|
|
Candesartan Cilexetil | HPLC |
|
Paracetamol | HPLC |
|
|
Chlorpheniramine | HPLC |
|
Peginterferon | HPLC |
|
|
Ciprofloxacin | HPLC |
|
Pseudoephedrine | HPLC |
|
|
Clarithromycin | LC-MS/MS |
|
Valsartan | HPLC |
|
|
Cycloserine | HPLC |
|
Omeprazole | HPLC |
|
|
Diclofenac | HPLC |
|
Spironolactone | HPLC |
|
|
Ethionamide | HPLC |
|
Clopidogrel | LC-MS/MS |
|
|
Gabapentin | HPLC |
|
Lamotrigine | HPLC |
|
|
Hydrochlorothiazide | HPLC |
|
Rivaroxaban | HPLC |
|
|
Levofloxacin | HPLC |
|
Losartan Potassium | HPLC |
|
|
Dexlansoprazole | HPLC |
|
Sofosbuvir+Valpatasvir | HPLC |
|
|
Ticagrelor | HPLC |
|
Declatasvir | HPLC |
|
|
Montelukast | HPLC |
|
Cefixime | HPLC |
|
|
Pregabalin | HPLC |
|
Metformin | HPLC |
|
|
Empagliflozin + Metformin | HPLC |
|
Drotaverine | HPLC |
|
|
Salsalate +Salicylic Acid (Plasma) | HPLC |
|
Salsalate + Salicylic Acid + Salicyluric Acid (Urine) |
HPLC |
|
|
Rosuvastatin | LC-MS/MS |
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Escitalopram | LC-MS/MS |
|
|
Ibuprofen | HPLC |
|
Sacubitril/Valsartan | HPLC |
4.Toxicological Studies:
CBSCR has also build-up the capacity and developed test methods for Toxicological studies on Pesticides and other chemicals as per OECD guidelines. These pre-clinical studiesare accredited for ISO 17025 by Pakistan National Accreditation Council(PNAC)for Toxicological Lab:
CBSCR has also build-up the capacity and developed test methods for Toxicological studies on Pesticides and other chemicals as per OECD guidelines. These pre-clinical studiesare accredited for ISO 17025 by Pakistan National Accreditation Council(PNAC)for Toxicological Lab:
- Acute Dermal Irritation/ Corrosion
- Acute Dermal Toxicity (Dermal LD50)
- Acute Eye Irritation / Corrosion
- Acute Oral Toxicity (Oral LD50)
- Skin Sensitization
Clinical Trial Management Phase II- III​
- Traditional Chinese Medicine (TCM), as a major component of complementary and alternative medicine remedies, has attracted increasing attention worldwide because of its satisfactory clinical efficacy. After successful execution of first ever clinical trial on Traditional Chinese medicine in Pakistan, CBSCR has initiated a number of clinical trials (Phase I, Phase II, Phase III) with well reputed Chinese Pharma companies
- Phase I Clinical Trial on COVID-19 Vaccine.
- CBSCR is also a Drug Regulatory Authority of Pakistan (DRAP) approved Clinical Trial Unit
- CBSCR is also is also a Drug Regulatory Authority of Pakistan (DRAP) approved CRO for clinical trial management
- Successful completed of a number of clinical trials (Phase I, Phase II and Phase III) on Traditional Chinese Medicine (TCM) in Pakistan.
Contact Us
Prof. Dr. M. Raza Shah T.I.
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
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
Center for Bioequivalence Studies and Clinical Research (CBSCR)
Dr. Panjwani Center for Molecular Medicine and Drug Research (PCMD)
International Center for Chemical and Biological Sciences (ICCBS)
University of Karachi,
Karachi, Pakistan
UAN #: (92-21) 111-222-292
Tel:(92-21)992617012,3482493034-36,3482490102
Fax: (92-21) 34819018, 99261713
Dr. Panjwani Center for Molecular Medicine and Drug Research (PCMD)
International Center for Chemical and Biological Sciences (ICCBS)
University of Karachi,
Karachi, Pakistan
UAN #: (92-21) 111-222-292
Tel:(92-21)992617012,3482493034-36,3482490102
Fax: (92-21) 34819018, 99261713
Email: cbscr@iccs.edu
Web: https://iccs.edu/page-cbscr
LinkedIn: https://www.linkedin.com/company/center-for-bioequivalence-studies-and-clinical-research
Facebook: https://m.facebook.com/p/Center-for- Bioequivalence-Studies-and-Clinical-Research- 100083620595619