Services

Explore how our services can accelerate your research journey and contribute to groundbreaking advancements in medical science

Clinical Management Services

CRC’s clinical trial management team understand the significance of obtaining accurate and realistic feasibility to assist our clients in making critical decisions regarding the design and planning of Clinical Trials. CRC has access to qualified, well-equipped, and adequately supported clinical sites. It assists our clients in making critical strategic decisions by aligning various regional data sets. To manage complex treatment feasibilities, CRC has internationally experienced and trained professionals. We ensure that the feasibility has been established using only the necessary facts and environment. CRC team visits the clinical sites to assess the qualification, training, ICH-GCP compliance, and, most crucially, the patient population for the required trial design.

CRC understand the need for modern-day clinical trials and the laboratory function for trial subjects in accordance with regulatory standards.. The CRC team has previous experience working with top laboratories. The labs provide qualified phlebotomists for blood sampling and other protocol-required procedures. The Lab provides onsite and offsite blood sampling for trial’s subjects as per ethics and regulatory requirements.

CRC is the CRO for you if you need local monitoring experience for your multinational global or regional Clinical Trials. We have the knowledge, experience, and resources to achieve the quality and efficiency required to connect with your worldwide project management and clinical trial delivery goals. Our team bring strong monitoring and clinical experience to our customers. Furthermore, each member has received training in FDA/EMEA rules, local IRB/EC laws, ICH guidelines, and GCP/SOP compliance. As a result, our local monitors have a solid understanding of the many intricacies inherent with global or regional trials. 

Every project provides a unique difficulty and necessitates a unique data management solution. CRC will work with client throughout the course of trial to ensure a successful outcome. CRC will collaborate with client to deliver accurate and insightful clinical trial data management from recording to reporting. CRC also assist with clinical study data entry, data transfer and statistical analysis. A team of competent statisticians with therapeutic experience contributes to study design, sample size calculation, statistical analysis strategy, and reporting. To provide high-quality data, all processes are carried out in accordance with SOPs. Transparency is something on which we place a high priority.

Drug Development Services

CRC provide formulation development services across multiple dosage forms.
 – Oral Solids dosage like tablets & capsules
 – Dry Powder suspensions
 – Eye and topical/skin Ointments
 – Nasal Sprays
 – Injectables in dry powder and liquid form
 – Oral liquids dosage form like:
  • Syrups
  • Solutions
  • Suspensions and emulsions

Development of protocols requires an expert, dynamic and collaborative team. CRC’s clinical operation team, medical writers and biostatisticians make a highly expert, inventive, and agile protocol development teams that assist sponsors in achieving scientific and logistical excellence in the creation of their phase 1 to phase 4 protocols..

PK/PD analyses are useful because they help us understand how medications function in the body and how the body reacts to these drugs. Data from PK and PD analyses is used by drug developers to plan better clinical studies. PK/PD analyses and modeling can be used to determine a number of important drug development parameters related to clinical study design. CRC’s team actively engaged in providing PK/PD data to facilitate clients in planning better clinical studies.

The efficacy and toxicity of the potential drug can be investigated with the help of different in vitro and in vivo experiments. CRC expert research team facilitate in making in-vitro/in-vivo models to verify the efficacy or toxicity of a drug that is expected to be launched in the pharmaceutical market.

CRC’s Regulatory Affairs team is a niche scientific and regulatory consulting group.We advise and assist pharmaceutical, biotech, and healthcare companies in the development and implementation of innovative and global regulatory strategies to accelerate the development and registration of drugs, biologics, medical devices, combination products, and other healthcare products at all stages of development.

Post marketing surveillance (Phase IV) is part of the drug development process and is mandated by the pharmaceutical regulators bodies. This is to allow for the collection of safety and efficacy data once a drug has received marketing approval and to assess how it performs in ‘the clinical setting’. CRC’s professionals provide comprehensive planning for the collection of such data.

Bioequivalence/Pharmacovigilance Studies

CRC, in collaboration with prominent organisations, manages Phase I and BA/BE studies in cutting-edge clinical facilities in accordance with ICH-GCP and regulatory standards. We have a big registered volunteer database and can provide clients with the finest solutions for Phase-I and BA/BE studies in terms of ethics, quality monitoring, subject compliance, site assessment, trainings, and data integrity.
In the process of providing successful solutions to biopharmaceutical/pharmaceutical clients, a highly skilled CRC team of leading medical specialists prioritises volunteer safety. Volunteers who choose us put themselves in the hands of some of the most qualified and experienced researchers.
To ensure on-time reporting, CRC has an experienced and client-focused team that receives and triages serious and non-serious  Adverse Event (AE) cases, performs extensive case entry and follow-up, narrative writing, quality and medical reviews. It includes the following services:
– Pharmacovigilance inspection and audit
– Pharmacovigilance systems
– Case processing and expedited reporting for clinical trials and post marketing surveillance
– Safety databases
– Aggregate reports
– Signal management
– Risk management planning
– Safety reporting to regulatory authorities
– National, regional and local qualified person for Pharmacovigilance
– Literature screening for Pharmacovigilance
– Receipt of AE
-Receipt of product quality complaints

Laboratory Services

Stability testing is essential for the development of new pharmaceutical products and active pharmaceutical ingredients, to establish their shelf life or expiry date. Along with ongoing routine manufacturing, it is also critical to monitor product quality as a function of time. CRC provide a complete solution to client’s requirements of Stability Studies for Shelf-Life Estimation during:
 – Product Development
 – Product Shelf life Evaluation
 – Packing Material Development & Change Over
 – For Product Registration in Global Markets

The purpose of a limit test is to find impurities in a substance and compare it to a standard. Limit tests are generally defined as quantitative or semi-quantitative tests meant to discover and control small amounts of impurity that are expected to be present in the substance. CRC laboratory services exclusively provide this facility to pharmaceutical industry clients to get the data of quantitative or semi-quantitative limit tests

This assay is performed to establish the possible effectiveness of specific antibiotics on bacteria and/or whether bacteria have evolved resistance to specific antibiotics. The results of this test can be used to aid in the selection of the drug(s) most likely to be beneficial in treating an infection. CRC Lab provided exclusive facility to researchers and clients for antimicrobial susceptibility assays during the process of drug development.

A series of preclinical toxicity studies must be performed before the first clinical trial of a new medicine and before it is licensed for commercialisation to offer information on the new drug’s safety. In addition to give recommendations for the safety assessment of phase I clinical trials, ICH also provides guidelines for non-clinical trials of different types of toxicity (reproductive and developmental toxicity, carcinogenicity) and long-term toxicity tests to support the marketing approval of new drug products. CRC laboratory team can assist new drug developers to complete new drug safety evaluation cases and clinical trials.

Medical Writing Services

Scientific/Medical Writing is the preparation and compilation of scientific and technical regulatory documentation required for the development, registration, launch, and lifecycle management of medicinal products. CRC can provide you with high-quality scientific writing services to help clients through the full regulatory application procedure.
CRC’s team of skilled and experienced scientific writers provide expert scientific and medical writing and reviewing services for non-clinical, clinical, pharmacovigilance and regulatory documents. They meticulously capture key massages that support client’s regulatory strategy in clear and concise manner, crafting technical document of exceptional quality.
CRC also include extensive details on the course of treatment for patients, the medical information collected from the patients as part of the research, and demographic data, as well as other kinds of information to explain how the trial was conducted and results were analyzed. CRC Manage constantly evolving regulatory protocols and submission guidelines with our medical writing experts.

The outcomes of a clinical study are presented in statistical reports in the form of tables, figures, and lists (TFLs). Statistical programmers create these reports by using statistical software to construct TFLs in accordance with the statistical analysis plan. Clinical trial statistics reports contain a variety of data, most notably results relating to drug administration, efficacy, and safety, as well as descriptive summaries of demographics, medical history, and other patient characteristics. CRC’s medical writers and biostatisticians team deals with this aspect and generate comprehensive results of clinical trials as expected by the clients.

Data Science and metadata research is a multi-disciplinary field, bringing together different computational and mathematical skills with a strong knowledge of clinical trials and healthcare. CRC’s data science team augments our high-quality biostatistics, programming, and data management capabilities to offer a more comprehensive set of services to make the best use of data and metadata.With technical skills in data processing, analytics, machine learning, artificial intelligence and algorithm development, the CRC helps pharmaceutical, biotechnology, and medical device firms with data-related challenges.

Other Services

The CRC training services offers a wide range of courses that can be tailored to client’s specific requirements. Our courses range from the essential topics in Clinical Research, Good Clinical Practice to highly specialised best practices in:
 – Scientific/Medical Writing
 – Biostatistics
 – Medical Coding
 – Pharmacovigilance and
 – Health Economics
To ensure meeting client’s expectations of providing training solutions that fit in different situations, CRC provide training services through On-line, On-site, and In-house.
The CRC offers consultancy in all health and pharmaceutical related issues including:
 – Product development
 – Health and Pharma facility development
 – Drug licensing
 – R&D development
 – QA & QC of product
 – Marketing
 – Recruitments etc. 
CRC marketing and consultancy experts facilitate clients in creating marketing strategies and implementing protocols & strategies to focus on achieving growth.

Have Question or Ready to Collaborate?

Reach out to us today and discover how our CRC can partner with you to drive transformation advancement in healthcare

Contact us

Address

First Floor, Anwaaria Resturant Plaza, Satellite Town, GT Road, Wah Cantt, Tehsil Taxila, Pakistan 47010

Call Us

+92 316 545 2651

Landline

+92 51 ---------

Email Us

Support@continuumrc.com