HCL Technologies has a successful history of handling complex and sensitive interactions in the life sciences industry.
We have the Process, the People, and the Technology needed to deliver high quality, scalable, product safety solutions to meet your ever-growing needs. From clinical development to post-approval services, HCL is redefining the standard for drug safety by utilizing “best of practice” processes and workflows. Our staff is comprised entirely of Healthcare Professionals who assess, process, and medically review safety data using their clinical background and judgment.
By incorporating multi-channel technology and strict adherence to global regulatory guidelines, HCL is the perfect addition to your safety strategy.
If you’re a large pharmaceutical manufacturer, optimizing drug safety across your entire marketed portfolio, let us help you keep pace with evolving global regulation and reporting transparency.
If you’re a smaller biotech with a single emerging compound, our scalable and flexible solutions can grow with you. As your case volumes increase significantly due to larger patient populations or more products on the market, we will be with you every step of the way.
Learn more about our services:
Safety Reporting: Why We Do What We Do
We participate in safety reporting not only because it is required by law, but because we are HCPs whose first duty is always to protect the patient.
EMA and Brexit Yet Again: Part 3
Bart Cobert highlights the ongoing saga with EMA and Brexit. In this post, he elaborates on the lack of a current Brexit deal between the EU and the UK.
Drug Safety and AEs in Children
As the saying goes, children are not small adults. Thus the approach of pharmacovigilance to AEs in children needs to be different from that in adults.
DMCs and SACs
Bart Cobert examines the importance of, and differences between Data Monitoring Committees (DMCs) & Safety Assessment Committees (SACs).
Medical Monitoring 101: Providing Medical Expertise for Clinical Trials
Exploring the role of the Medical Monitor in the clinical research process.
Animal Health 101: Key Components of a Veterinary PV Program
As in the human medical sciences field, the world of veterinary PV is constantly evolving. Explore the 4 main components of an animal health PV program.
Pharmacovigilance and Medical Information Services