Why pharma and life sciences teams use e-signatures
Contracting is one of the slowest parts of bringing a medicine or device to market. Before a site can be selected for a study, it needs a signed confidentiality agreement. Before it can enrol a patient, the clinical trial agreement and budget must be signed by the sponsor or CRO, the institution and often the principal investigator. Add consultant agreements with healthcare professionals, licensing deals with biotech partners and supply contracts with manufacturers, and a single programme can generate hundreds of agreements across several countries.
SignPe takes the printing, couriering and scanning out of those business agreements. Upload the contract — PDF, Word (DOC or DOCX) or an image — place the fields each party must complete, and send it. Each signer receives an email with a Review & Sign Document button and signs in their browser. When everyone has signed, all parties receive the signed PDF and you can download an audit trail of every step.
Business agreements, not GxP records
Regulated GxP records — for example electronic records and signatures that fall under the US FDA’s 21 CFR Part 11 or the EU’s Annex 11 — have specific requirements for system validation, signature controls and record-keeping. SignPe does not claim to meet them. Use SignPe for business agreements your quality and compliance function has agreed are out of GxP scope, and confirm with them before using it for anything else.
Confidentiality agreements with sites, CROs and partners
Confidentiality disclosure agreements are the first document in almost every life sciences relationship: with a prospective investigator before a protocol synopsis is shared, with a CRO before a study is scoped, with a biotech before licensing data is opened up, with a contract manufacturer before a process is discussed. They are usually standard, often urgent, and they hold everything else up while they wait.
- Guests sign without an account. Investigators, site contracts officers and partner counsel sign from their email link after accepting an electronic-records consent screen — nothing to install.
- Your side signs once, in order. Use Set signer order so the counterparty signs first and your authorised signatory countersigns after.
- Business development kept in the loop. Copy the study manager or business development lead as observers so they know the moment a CDA is done.
- Send it from your phone. Open the CDA from Dropbox, Google Drive, OneDrive or Box in the SignPe app, place the fields and send.
Our guide to signing an NDA online walks through the process from both sides.
Clinical trial agreements and site contracts
A clinical trial agreement is a classic multi-party contract. The sponsor or CRO, the research institution and the principal investigator may all need to sign, often with a budget and payment schedule attached, and sometimes with separate signatures from the institution’s legal office and finance. Tracking who has signed across dozens of sites in several countries is a full-time job on paper.
- Every party on one document. Add each signatory — there is no limit on signers per document — and give each their own Signature, Full Name, Designation and Date fields.
- The order your process requires. Set signer order routes the agreement from site to institution to sponsor. Anyone who opens it early sees “Waiting for <name> to sign”.
- Budgets travel with the contract. Pages are unlimited, so the budget, payment schedule and other exhibits can go out in the same file, with Initials on the pages that carry them.
- Status across every site. The Waiting for Others filter shows every agreement still pending, and each one records Sent, Opened and Signed with dates and times.
Informed consent is a different document
Participant informed consent forms are governed by trial regulations, ethics committees and institutional review boards, and electronic consent in a trial has its own requirements. Confirm with your quality function and the relevant ethics body before using any e-signature tool for participant consent.
Consulting, speaker and advisory board agreements
Medical affairs and commercial teams engage healthcare professionals as consultants, speakers and advisory board members, and each engagement needs a signed agreement before the work starts — sometimes days before an advisory board meeting. The HCP is usually a busy clinician who will sign on a phone between patients, or not at all.
- Signing that suits a clinician. The signing page works in any modern mobile browser, and the speed-sensitive drawing pad makes a finger signature look natural.
- Every obligation acknowledged. Place Checkmark fields beside confidentiality, disclosure and compliance terms the consultant must confirm.
- Reminders before the meeting. Choose Remind and every signer who has not signed yet receives an email; signers with the SignPe app also get a push and in-app notification.
- Aadhaar eSign in India. For Indian agreements where signer identity matters, Aadhaar eSign adds OTP verification through eMudhra and a PKI-signed PDF.
Interactions with healthcare professionals are subject to industry codes and, in many countries, transparency reporting rules. SignPe records the signature; your compliance team decides what the agreement must say and how it is reported.
Licensing, supplier and distribution agreements
Beyond clinical work, life sciences companies sign licensing and collaboration agreements, contract manufacturing and supply agreements, distribution agreements and service contracts with laboratories and logistics providers. These usually need several signatories on each side and a legal team who must know when they are complete.
| Agreement | Who usually signs | What helps in SignPe |
|---|---|---|
| Confidentiality disclosure agreement | Counterparty, your authorised signatory | Guest signing, Set signer order, observers |
| Clinical trial agreement | Site, institution, investigator, sponsor or CRO | Unlimited signers, signer order, Initials on budget pages |
| HCP consulting agreement | Consultant, medical affairs signatory | Mobile signing, Checkmark fields, Remind |
| Licensing or distribution agreement | Both companies’ authorised signatories | Company and Designation fields, company stamp, delegation |
Quality agreements and other documents that support GxP activities may fall within your quality system’s scope even though they look like ordinary contracts — check with your quality function first. Where a signatory is travelling, they can delegate their signing to a colleague in the same organisation, who signs on their behalf; the delegate is notified. If a counterparty disagrees with a clause, they can choose Decline to sign? and you are notified straight away.
A typical life sciences contracting workflow
Prepare the agreement
Upload the CDA, site agreement or consulting contract as a PDF or Word file, or import it from cloud storage. Save it as a draft while terms are finalised — drafts don’t use a document credit.
Place and assign fields
Add Signature, Full Name, Designation, Company and Date fields for each signatory, Initials on budget pages, and Checkmarks beside key obligations.
Set the order and observers
Choose Set signer order to match your signature routing, and copy the study manager, legal or business development as observers.
Track and remind
Watch the Activity timeline move through Sent, Opened and Signed. Use Remind for anyone still pending as site activation approaches.
File the signed agreement
When everyone has signed, all parties receive the signed PDF. Download it and the audit trail PDF and store them in your own contract or study files.
Compliance considerations for pharma and life sciences
Commercial agreements such as CDAs, consulting contracts and supply agreements are widely signed electronically, and e-signatures are recognised under laws including the US ESIGN Act and UETA, the EU’s eIDAS regulation and India’s Information Technology Act 2000. Life sciences adds a regulated layer on top. Electronic records and signatures used in GxP activities — clinical, manufacturing, laboratory and quality records — carry specific requirements, such as those in 21 CFR Part 11 and EU Annex 11. SignPe makes no claim to satisfy them, so confirm with your quality and compliance function which documents are appropriate for SignPe.
- An audit trail per document. The downloadable audit trail shows the document ID, sent and completed dates, and when each signer was emailed, viewed and signed.
- Access limited to participants. Only the sender, signers and observers on a document can open it, and signers only see the document they were asked to sign.
- Encryption in transit and at rest. Documents travel over HTTPS/TLS and are stored in encrypted cloud storage — see eSignature security.
- Void anything sent in error. If a document goes to the wrong person, void it at once so the signing link stops working for everyone.
Agreements can contain confidential study and commercial information, and some contain personal data. Send only the document that needs signing, keep the list of observers short, and apply your own retention policies to the signed copies you download. The legality guide covers e-signature law in India in detail.
How to send a confidentiality agreement to a research site
Upload the CDA
Upload the confidentiality agreement as a PDF or Word file, or import it from cloud storage.
Add the signers
Choose Set signer order. Add the investigator or site contracts officer first and your authorised signatory last, and copy the study manager as an observer.
Place the fields
Add Signature, Full Name, Designation and Date fields for each signer.
Send and follow up
The site is emailed a Review & Sign Document link. Watch for the Opened status and use Remind if needed.
Receive the signed copy
Once your signatory countersigns, everyone receives the signed PDF and the audit trail is ready to download.
